Flexicare Medical Ltd.
RHONDDA CYNON TAFF Wales, GB
FLEXICARE MEDICAL LTD. appears in FDA device records in RHONDDA CYNON TAFF Wales, GB. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Flexicare Medical Ltd. between 1995 and 2026. The busiest year on record is 2009, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 2009 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251448 | FL-10000U Respiratory Humidifier | BTT | Substantially Equivalent | |
| K250243 | ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) | BTR | Substantially Equivalent | |
| K201666 | SINGLE USE MANOMETER | CAP | Substantially Equivalent | |
| K191909 | HepaShield Bacterial Viral Breathing System Filter | CAH | Substantially Equivalent | |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 | BTM | Substantially Equivalent | |
| K163300 | ThermoShield HME Filter | CAH | Substantially Equivalent | |
| K161314 | FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE | BTT | Substantially Equivalent | |
| K160540 | FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM | BZE | Substantially Equivalent | |
| K150900 | Flexicare Heated Wire Breathing Systems | BZE | Substantially Equivalent | |
| K140473 | DUALGUARD | CCK | Substantially Equivalent | |
| K140113 | O2 NASAL CANNULA WITH CO2 MONITORING | CCK | Substantially Equivalent | |
| K132619 | CLASSIC INTERMITTENT CATHETER | EZD | Substantially Equivalent | |
| K092218 | FLEXICARE BREATHING FILTERS | CAH | Substantially Equivalent | |
| K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | |
| K951652 | VENTIMASK MK IV | BYF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8021995 | 3006363476 | FLEXICARE MEDICAL LTD. | CYNON VALLEY BUSINESS PARK, RHONDDA CYNON TAFF Wales CF45 4ER GB | 2026 | and 39 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBLAbsorbent, Carbon-Dioxide
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BTCBag, Reservoir
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- CATCannula, Nasal, Oxygen
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- JOLCatheter And Tip, Suction
- EZDCatheter, Straight
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- HXDClamp
- BXJClip, Nose
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- CBHDevice, Fixation, Tracheal Tube
- BYHDrain, Tee (Water Trap)
- MNKEndoscopic Bite Block
- IONExerciser, Non-Measuring
- CAHFilter, Bacterial, Breathing-Circuit
- HTDForceps
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- FPLIncubator, Neonatal Transport
- CCWLaryngoscope, Rigid
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- KGBMask, Oxygen, Non-Rebreathing
- KHAMask, Scavenging
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- BYIPercussor, Powered-Electric
- KBWScrew, Oral
- BZOSet, Tubing And Support, Ventilator (W Harness)
- FOXStand, Infusion
- BTKStrap, Head, Gas Mask
- BSRStylet, Tracheal Tube
- NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- BTRTube, Tracheal (W/Wo Connector)
- GAZTubing, Noninvasive
- BYXTubing, Pressure And Accessories
- JRLUnit, Filter, Membrane
- EXRUrinometer, Mechanical
- BTMVentilator, Emergency, Manual (Resuscitator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0497-2021 | ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers | When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the patient. | Class I | Terminated | |
| Z-0804-2020 | BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320 | The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts. | Class II | Terminated | |
| Z-0803-2020 | BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis. | The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts. | Class II | Terminated | |
| Z-0802-2020 | BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis. | The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts. | Class II | Terminated | |
| Z-0801-2020 | BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis. | The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain