Respironics, Inc.
Murrysville, PA, US
RESPIRONICS, INC. appears in FDA device records in Murrysville, PA. FDA records list 186 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 216 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Respironics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Philips Respironics, Inc.510(k), enforcement report, recall
- Phillips Respironics, Inc.enforcement report, recall
- Respironics California, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 186FDA records hold 186 510(k) clearances for Respironics, Inc. between 1977 and 2024. The busiest year on record is 1996, with 13. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1981 | 1 |
| 1982 | 2 |
| 1983 | 3 |
| 1984 | 3 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 3 |
| 1990 | 2 |
| 1991 | 3 |
| 1992 | 2 |
| 1993 | 4 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 13 |
| 1997 | 4 |
| 1998 | 5 |
| 1999 | 10 |
| 2000 | 5 |
| 2001 | 5 |
| 2002 | 5 |
| 2003 | 6 |
| 2004 | 12 |
| 2005 | 8 |
| 2006 | 6 |
| 2007 | 6 |
| 2008 | 4 |
| 2009 | 5 |
| 2010 | 7 |
| 2011 | 11 |
| 2012 | 10 |
| 2013 | 5 |
| 2014 | 2 |
| 2015 | 5 |
| 2016 | 2 |
| 2017 | 1 |
| 2019 | 5 |
| 2020 | 3 |
| 2021 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243394 | AF531 Oro-Nasal SE Face Mask | CBK | Substantially Equivalent | |
| K233555 | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask | BZD | Substantially Equivalent | |
| K231313 | Therapy Mask 3100 NC/SP | BZD | Substantially Equivalent | |
| K210844 | DreamWear Silicone Pillows Mask | BZD | Substantially Equivalent | |
| K210386 | Magneto Nasal Mask | BZD | Substantially Equivalent | |
| K202142 | Sleepware G3 | OLZ | Substantially Equivalent | |
| K201439 | Ventilator, Non-continuous (Respirator) | BZD | Substantially Equivalent | |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | BZD | Substantially Equivalent | |
| K183625 | SomnaPatch | MNR | Substantially Equivalent | |
| K183226 | Care Orchestrator Essence | BZD | Substantially Equivalent | |
| K181170 | Trilogy Evo Universal | CBK | Substantially Equivalent | |
| K181166 | Trilogy Evo | CBK | Substantially Equivalent | |
| K181053 | Care Orchestrator | BZD | Substantially Equivalent | |
| K161411 | Care Cycle Connect Application | MOD | Substantially Equivalent | |
| K151120 | Simple T Pediatric Nasal Mask | BZD | Substantially Equivalent | |
| K152356 | Sapphire | BZD | Substantially Equivalent | |
| K150639 | AF541 EE Full Face Mask | BZD | Substantially Equivalent | |
| K150638 | AF541 SE Full Face Mask | CBK | Substantially Equivalent | |
| K142988 | Sleepware G3 | OLZ | Substantially Equivalent | |
| K140980 | TI NASAL MASK | BZD | Substantially Equivalent | |
| K142554 | Revolution Full Face Mask | BZD | Substantially Equivalent | |
| K140424 | RESPIRONICS REUSABLE HEATED TUBING | BZE | Substantially Equivalent | |
| K140268 | SIMPLE T YOUTH NASAL MASK | BZD | Substantially Equivalent | |
| K132168 | BRONCHOSCOPY ELBOW | BZD | Substantially Equivalent | |
| K131982 | REMSTAR AUTO A-FLEX HT | BZD | Substantially Equivalent | |
| K131994 | SOMNOLYZER 24X7 | MNR | Substantially Equivalent | |
| K130077 | REMSTAR SE | BZD | Substantially Equivalent | |
| K122847 | KANGAROO NASAL MASK | BZD | Substantially Equivalent | |
| K122111 | RESPIRONICS SIMPLYCLEAR DEVICE | SDT | Substantially Equivalent | |
| K121955 | COUGHASSIST T70 DEVICE | NHJ | Substantially Equivalent | |
| K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | MNT | Substantially Equivalent | |
| K122769 | REMSTAR SE | BZD | Substantially Equivalent | |
| K121631 | SIMPLE T NASAL MASK | BZD | Substantially Equivalent | |
| K120562 | PERFORMAX PEDIATRIC EE TOTAL FACE MASK | BZD | Substantially Equivalent | |
| K120639 | PERFORMAX PEDIATRIC SE TOTAL FACE MASK | CBK | Substantially Equivalent | |
| K120145 | SIMPLE T NASAL MASK | BZD | Substantially Equivalent | |
| K113053 | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | MNS | Substantially Equivalent | |
| K110083 | V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE | CBK | Substantially Equivalent | |
| K113068 | REMSTAR AUTO A-FLEX HT | BZD | Substantially Equivalent | |
| K111885 | SIMPLYGO PORTABLE OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | |
| K111610 | TRILOGY SERIES VENTILATOR WITH OXIMETRY | CBK | Substantially Equivalent | |
| K111378 | OXIMETRY INTERFACE KIT | MNS | Substantially Equivalent | |
| K110795 | V200 INTELLI-TRAK OPTION | CBK | Substantially Equivalent | |
| K110405 | TRUBLUE NASAL MASK | BZD | Substantially Equivalent | |
| K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | BZE | Substantially Equivalent | |
| K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | MNT | Substantially Equivalent | |
| K103395 | PERFORMAX TOTAL FACE MASK | BZD | Substantially Equivalent | |
| K102465 | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | MNS | Substantially Equivalent | |
| K110008 | GOLIFE NASAL MASK | BZD | Substantially Equivalent | |
| K102502 | GOLIFE NASAL MASK | BZD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2518422 | 2518422 | RESPIRONICS INC. | 1001 Murry Ridge Lane, MURRYSVILLE, PA 15668 US | 2026 | and 33 more, listed in full below |
| 3002797442 | 3002797442 | RESPIRONICS, INC. | 174 Tech Center Drive, Mount Pleasant, PA 15666 US | 2026 | and 5 more, listed in full below |
| 3007220521 | 3007220521 | RESPIRONICS, INC. | 312 Alvin Drive, New Kensington, PA 15068 US | 2026 | |
| 3027553886 | 3027553886 | Respironics, Inc. | Coyol Free Zone and Business Park, Building B37, Coyol Alajuela 20101 CR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MODAccessory To Continuous Ventilator (Respirator)
- CAOAirway, Esophageal (Obturator)
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- BZCCalculator, Pulmonary Function Data
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BTICompressor, Air, Portable
- GWKConditioner, Signal, Physiological
- NFBConserver, Oxygen
- FLLContinuous Measurement Thermometer
- MNTContinuous, Minimal Ventilatory Support, Facility Use Ventilator
- NOUContinuous, Ventilator, Home Use
- BSKCuff, Tracheal Tube, Inflatable
- LRKDevice, Anti-Snoring
- HCCDevice, Biofeedback
- CBHDevice, Fixation, Tracheal Tube
- NHJDevice, Positive Pressure Breathing, Intermittent
- LELDevice, Sleep Assessment
- BYHDrain, Tee (Water Trap)
- DRXElectrode, Electrocardiograph
- GWQFull-Montage Standard Electroencephalograph
- KGKGas, Collecting Vessel
- CAWGenerator, Oxygen, Portable
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- NVPHolding Chambers, Direct Patient Interface
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- MPOInfant Heel Warmer (Chemical Heat Pack)
- KMAIrrigator, Powered Nasal
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- BZHMeter, Peak Flow, Spirometry
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- NPFMonitor, Apnea, Home Use
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- DQAOximeter
- MYBPillow, Cervical (For Mild Sleep Apnea)
- FMPProtector, Skin Pressure
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BZGSpirometer, Diagnostic
- BWFSpirometer, Therapeutic (Incentive)
- FOXStand, Infusion
- BTKStrap, Head, Gas Mask
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- KNTTubes, Gastrointestinal (And Accessories)
- BYXTubing, Pressure And Accessories
- BYJUnit, Liquid-Oxygen, Portable
- LBIUnit, Neonatal Phototherapy
- CBPValve, Non-Rebreathing
- CBKVentilator, Continuous, Facility Use
- MNSVentilator, Continuous, Non-Life-Supporting
- BTMVentilator, Emergency, Manual (Resuscitator)
- BYTVentilator, External Body, Negative Pressure, Adult (Cuirass)
- BZDVentilator, Non-Continuous (Respirator)
- MNRVentilatory Effort Recorder
Recall records
Showing 25 of 216| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1649-2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device. | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | Class I | Open, Classified | |
| Z-1648-2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | Class I | Open, Classified | |
| Z-1647-2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | Class I | Open, Classified | |
| Z-1646-2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | Class I | Open, Classified | |
| Z-1617-2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device. | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. | Class I | Open, Classified | |
| Z-1616-2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device. | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. | Class I | Open, Classified | |
| Z-1615-2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device. | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. | Class I | Open, Classified | |
| Z-1614-2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. | Class I | Open, Classified | |
| Z-0481-2026 | SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600 | Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini. | Class II | Open, Classified | |
| Z-2229-2025 | DreamStation Auto. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Open, Classified | |
| Z-2228-2025 | DreamStation Auto BiPAP. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Open, Classified | |
| Z-2227-2025 | DreamStation Auto CPAP. Non-Continuous Ventilator. | Devices may possess a programming error resulting in an incorrect device configuration. | Class I | Open, Classified | |
| Z-2037-2025 | BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS | This device does not indicate for use in patients with respiratory failure. | Class I | Open, Classified | |
| Z-2036-2025 | BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. | This device does not indicate for use in patients with respiratory failure. | Class I | Open, Classified | |
| Z-2035-2025 | BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg. | This device does not indicate for use in patients with respiratory failure. | Class I | Open, Classified | |
| Z-0296-2025 | LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements. | Class I | Open, Classified | |
| Z-0295-2025 | Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements. | Class I | Open, Classified | |
| Z-0294-2025 | Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements. | Class I | Open, Classified | |
| Z-0293-2025 | Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements. | Class I | Open, Classified | |
| Z-0292-2025 | Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements. | Class I | Open, Classified | |
| Z-0291-2025 | Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B, EU2110X19, FP2110X10, PP2110X10, RBRBR2110X18B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements. | Class I | Open, Classified | |
| Z-0290-2025 | Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. | Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements. | Class I | Open, Classified | |
| Z-2944-2024 | Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15B Trilogy Evo, O2, EU EU2100X19 Trilogy Evo, O2, EU (Non-BT) EU2110X15B Trilogy Evo, EU EU2110X19 Trilogy Evo, EU (Non-BT) FR2100X14B Trilogy Evo O2, France FR2110X14B Trilogy Evo, France FX2100X15B Trilogy Evo, O2, INT GB2110X15B Trilogy Evo, Great Britain IA2100X15B Trilogy Evo O2, India IA2110X15B Trilogy Evo, India IN2100X15B Trilogy Evo, O2, International IN2100X19 Trilogy Evo, O2, International (Non-BT) IN2110X15B Trilogy Evo, International IT2100X21B Trilogy Evo O2, Italy IT2110X21B Trilogy Evo, Italy JP2100X16B Trilogy Evo, O2, Japan JP2110X16B Trilogy Evo, Japan KR2110X15B Trilogy Evo, Korea LA2100X15B Trilogy Evo, O2, Latin America LA2110X15B Trilogy Evo, Latin America LD2110X23B Garbin Evo, Linde ND2100X15B Trilogy Evo O2, Nordics ND2110X15B Trilogy Evo, Nordics RDS2110X11B Trilogy Evo, USA-Rental SP2100X26B LifeVentEVO2 TR2110X15B Trilogy Evo, Turkey UDS2110X11B Trilogy Evo, USA-RECERT VT2110X24B Aeris EVO | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. | Class I | Open, Classified | |
| Z-2943-2024 | Trilogy Evo Universal Ventilator, Model No. DS2000X11B | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. | Class I | Open, Classified | |
| Z-2942-2024 | Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Trilogy Evo, O2, INT EV300; GB2200X15B Trilogy Evo, O2, Great Britain EV300; IN2200X15B Trilogy Evo, O2, INTL EV300; IT2200X21B Trilogy Evo, O2, Italy EV300; KR2200X15B Trilogy Evo, O2, Korea EV300; ND2200X15B Trilogy Evo, O2, Nordics EV300; TR2200X15B Trilogy Evo, O2, Turkey EV300; | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls. | Class I | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain