Vital Signs, Inc.
Totowa, NJ, US
Vital Signs, Inc. appears in FDA device records in Totowa, NJ. FDA records list 75 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 9 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Vital Signs, 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.
- Vital Signs Devices, a GE Healthcare Companyenforcement report, recall
510(k) clearance history
Showing 50 of 75FDA records hold 75 510(k) clearances for Vital Signs, Inc. between 1979 and 2012. The busiest year on record is 1991, with 12. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 3 |
| 1980 | 4 |
| 1981 | 2 |
| 1982 | 5 |
| 1983 | 4 |
| 1984 | 3 |
| 1985 | 3 |
| 1986 | 3 |
| 1988 | 1 |
| 1990 | 1 |
| 1991 | 12 |
| 1992 | 7 |
| 1993 | 2 |
| 1994 | 6 |
| 1995 | 5 |
| 1996 | 1 |
| 1997 | 2 |
| 1999 | 2 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112902 | ENFLOW IV FLUID WARMER | LGZ | Substantially Equivalent | |
| K041309 | IMASK TM | BZD | Substantially Equivalent | |
| K030985 | BREAS PV 10I CPAP SYSTEM, MODEL PV 10I | BZD | Substantially Equivalent | |
| K022402 | DISPOSABLE PRESSURE MANOMETER | CAP | Substantially Equivalent | |
| K021315 | SURE-LOK | FMI | Substantially Equivalent | |
| K002454 | BREAS HA50 HUMIDIFIER, MODEL HA50 | BTT | Substantially Equivalent | |
| K001553 | BREAS PV 100 CPAP SYSTEM | BZD | Substantially Equivalent | |
| K000441 | BODYGUARD | FMI | Substantially Equivalent | |
| K994044 | CLEEN-ABLE | DXQ | Substantially Equivalent | |
| K990412 | CUFF-ABLE PLUS | DXQ | Substantially Equivalent | |
| K984468 | VITAL PEP | BWF | Substantially Equivalent | |
| K970196 | T-WALL UNCUFFED TRACHEAL TUBE | BTR | Substantially Equivalent | |
| K962438 | MISTY OX TURBOHEATER | CAF | Substantially Equivalent | |
| K955417 | VITAL PAK | DXG | Unknown | |
| K953120 | VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE | FOZ | Substantially Equivalent | |
| K952645 | VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE | FOZ | Substantially Equivalent | |
| K951047 | BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA | CAH | Substantially Equivalent | |
| K951745 | CONNECTING TUBE | BSY | Substantially Equivalent | |
| K950447 | FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT | BYD | Substantially Equivalent | |
| K945950 | TRIGUARD(TM) SUCTION SYSTEM | BSY | Substantially Equivalent | |
| K945455 | GENERAL ANESTHESIA SYSTEM | BTR | Unknown | |
| K944949 | GENERAL ANESTHESIA SYSTEM | BTK | Unknown | |
| K935546 | MAC/IV SEDATION KIT | BSZ | Unknown | |
| K934482 | VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600 | FLL | Substantially Equivalent | |
| K932347 | COMPACT MASK | KGB | Substantially Equivalent | |
| K923865 | 5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID | BYD | Substantially Equivalent | |
| K914370 | MECONIUM SUCTION DEVICE (MSD) | BTR | Substantially Equivalent | |
| K920885 | VENTILATOR CIRCUITS | CAH | Substantially Equivalent | |
| K912577 | BACTERIA FILTER | CAH | Substantially Equivalent | |
| K914335 | STRAP, HEAD, GAS MASK | BTK | Substantially Equivalent | |
| K914336 | BREATHE EASY | BYD | Substantially Equivalent | |
| K905273 | BAUMAN DISPOSABLE LARYNGOSCOPE BLADES | CCW | Substantially Equivalent | |
| K915277 | ENDOTRACHEAL CPAP SET | BTR | Substantially Equivalent | |
| K914337 | GAS SAMPLING INTERFACES | CCK | Substantially Equivalent | |
| K911465 | INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL | BZD | Substantially Equivalent | |
| K912652 | FLEX-ELBOW | BZA | Substantially Equivalent | |
| K912578 | 20CM/H20 PEEP VALVE | BYE | Substantially Equivalent | |
| K912650 | 1.1, 1.2, 1.3 TEMPERATURE PROBES | FLL | Substantially Equivalent | |
| K912626 | BOLUS XENON CIRCUIT | IYT | Substantially Equivalent | |
| K912625 | MOUTH TO MASK RESUSCITATOR | BTM | Substantially Equivalent | |
| K912638 | BLOOD PRESSURE CUFFS | DXQ | Substantially Equivalent | |
| K904899 | VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR | BTM | Substantially Equivalent | |
| K905450 | ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE | CAI | Substantially Equivalent | |
| K910856 | MANUAL RESUSCITATOR | BTM | Substantially Equivalent | |
| K904830 | BACTERIA FILTER | CAH | Substantially Equivalent | |
| K904874 | ADJUSTABLE PEEP VALVE | BYE | Substantially Equivalent | |
| K901728 | ONE-LUNG CPAP DEVICE | BYE | Substantially Equivalent | |
| K882319 | TELEMETRIC STETHOSCOPE | BZT | Substantially Equivalent | |
| K861981 | ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR | DRW | Substantially Equivalent | |
| K862003 | CIRCUIT ANES. BREATHING & COMPONENTS | CAI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DRWAdaptor, Lead Switching, Electrocardiograph
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBNApparatus, Gas-Scavenging
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- DXQBlood Pressure Cuff
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- FLLContinuous Measurement Thermometer
- DRXElectrode, Electrocardiograph
- CAHFilter, Bacterial, Breathing-Circuit
- BSZGas-Machine, Anesthesia
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- CCWLaryngoscope, Rigid
- LLWLaser, Neodymium:Yag For Gynecologic Use
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- KGBMask, Oxygen, Non-Rebreathing
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- CAFNebulizer (Direct Patient Interface)
- FMINeedle, Hypodermic, Single Lumen
- CANRegulator, Pressure, Gas Cylinder
- KDPRegulator, Vacuum
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BWFSpirometer, Therapeutic (Incentive)
- BZTStethoscope, Esophageal, With Electrical Conductors
- BTKStrap, Head, Gas Mask
- IYTSystem, Rebreathing, Radionuclide
- BTRTube, Tracheal (W/Wo Connector)
- BTMVentilator, Emergency, Manual (Resuscitator)
- BZDVentilator, Non-Continuous (Respirator)
- LGZWarmer, Thermal, Infusion Fluid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1959-2013 | Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring. | GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is intended for oro-esophageal and rectal use. As it pertains to esophageal placement, it has been brought to our attention that some users are inserting the probe | Class II | Terminated | |
| Z-0330-2013 | Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. | Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing. | Class II | Terminated | |
| Z-1972-2012 | enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. | The EnFlow Warmer Strap does not meet the requirements of the biocompatibility standard (ISO 10993) for products that may have contact with skin for less than 24 hours. | Class II | Terminated | |
| Z-0939-2012 | Broselow/Hinkle Pediatric Emergency System Vital Signs Inc. 20 Campus Road Totowa, NJ 07512 USA The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit | Povidone Iodine Pads included in the Vital Signs Broselow Pediatric Emergency Kit may be contaminated with Elizabethkinga meningoseptica. | Terminated | ||
| Z-3040-2011 | enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. | enFlow IV Fluid Warmer may have an issue which results in excessive external surface temperature on the underside of the warmer. | Terminated | ||
| Z-2848-2011 | Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300. The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation. | The Hygroscopic Condenser Humidifier (HCH) device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient. | Terminated | ||
| Z-2704-2011 | Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA The kit contains oxygen masks and blood pressure cuffs use on pediatric patients | Broselow Pediatric Emergency System Kit may contain oxygen masks that may contain a potentially sticky substance on the inside and/or outside of the mask. | Terminated | ||
| Z-2380-2010 | Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids. | The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male luer-lock fitting may be oversized and may not fit properly with standard female luer fittings. | Terminated | ||
| Z-1912-2009 | Broselow/Hinkle Pediatric Emergency System; Contents: 1 15 Ga Adjustable Length Sternal/Iliac aspiration Needle; 1 Extension Set, Sterile. Equipment Color Zone: Green, Single Patient use, INTRAOSSEUS Module, Product # 7700GIO, Vital Signs, Totowa, NJ. The Broselow/Hinkle Pediatric Emergency System is a convenience kit that contains various modules/components used for the emergency treatment of pediatric patients. The modules are color coded to accommodate patients of various sizes. | Not compatible: The luer connector on the Intraosseus needle provided does not fit securely on the luer connection of the IV Extension Set in the module. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain