Company ยท US
Vital Signs, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2012. Name variants (Inc, Corp, punctuation) are merged.
75510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 6 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 6 |
| CAH | Filter, Bacterial, Breathing-Circuit | 5 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 5 |
| BTR | Tube, Tracheal (W/Wo Connector) | 4 |
| BZD | Ventilator, Non-Continuous (Respirator) | 4 |
| BSJ | Mask, Gas, Anesthetic | 3 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 3 |
| DXQ | Blood Pressure Cuff | 3 |
| FLL | Continuous Measurement Thermometer | 3 |
| BSY | Catheters, Suction, Tracheobronchial | 2 |
| BTK | Strap, Head, Gas Mask | 2 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 |
| IYT | System, Rebreathing, Radionuclide | 2 |
| LGZ | Warmer, Thermal, Infusion Fluid | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 2012 | K112902 | ENFLOW IV FLUID WARMER Vital Signs, Inc. | LGZ |
| Jun 30, 2004 | K041309 | IMASK TM Vital Signs, Inc. | BZD |
| Oct 15, 2003 | K030985 | BREAS PV 10I CPAP SYSTEM, MODEL PV 10I Vital Signs, Inc. | BZD |
| Aug 22, 2002 | K022402 | DISPOSABLE PRESSURE MANOMETER Vital Signs, Inc. | CAP |
| Aug 21, 2002 | K021315 | SURE-LOK Vital Signs, Inc. | FMI |
| Mar 7, 2001 | K002454 | BREAS HA50 HUMIDIFIER, MODEL HA50 Vital Signs, Inc. | BTT |
| Aug 3, 2000 | K001553 | BREAS PV 100 CPAP SYSTEM Vital Signs, Inc. | BZD |
| Apr 11, 2000 | K000441 | BODYGUARD Vital Signs, Inc. | FMI |
| Feb 25, 2000 | K994044 | CLEEN-ABLE Vital Signs, Inc. | DXQ |
| Sep 1, 1999 | K990412 | CUFF-ABLE PLUS Vital Signs, Inc. | DXQ |
| Jun 1, 1999 | K984468 | VITAL PEP Vital Signs, Inc. | BWF |
| Aug 21, 1997 | K970196 | T-WALL UNCUFFED TRACHEAL TUBE Vital Signs, Inc. | BTR |
| Jan 13, 1997 | K962438 | MISTY OX TURBOHEATER Vital Signs, Inc. | CAF |
| Mar 8, 1996 | K955417 | VITAL PAK Vital Signs, Inc. | DXG |
| Dec 13, 1995 | K953120 | VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE Vital Signs, Inc. | FOZ |
| Dec 13, 1995 | K952645 | VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE Vital Signs, Inc. | FOZ |
| Jun 2, 1995 | K951047 | BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA Vital Signs, Inc. | CAH |
| May 30, 1995 | K951745 | CONNECTING TUBE Vital Signs, Inc. | BSY |
| Feb 21, 1995 | K950447 | FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT Vital Signs, Inc. | BYD |
| Dec 27, 1994 | K945950 | TRIGUARD(TM) SUCTION SYSTEM Vital Signs, Inc. | BSY |
| Dec 23, 1994 | K945455 | GENERAL ANESTHESIA SYSTEM Vital Signs, Inc. | BTR |
| Nov 14, 1994 | K944949 | GENERAL ANESTHESIA SYSTEM Vital Signs, Inc. | BTK |
| Jun 13, 1994 | K935546 | MAC/IV SEDATION KIT Vital Signs, Inc. | BSZ |
| May 2, 1994 | K934482 | VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600 Vital Signs, Inc. | FLL |
| Jan 10, 1994 | K932347 | COMPACT MASK Vital Signs, Inc. | KGB |
| Feb 1, 1993 | K923865 | 5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID Vital Signs, Inc. | BYD |
| Jan 6, 1993 | K914370 | MECONIUM SUCTION DEVICE (MSD) Vital Signs, Inc. | BTR |
| Oct 23, 1992 | K920885 | VENTILATOR CIRCUITS Vital Signs, Inc. | CAH |
| Apr 22, 1992 | K912577 | BACTERIA FILTER Vital Signs, Inc. | CAH |
| Apr 2, 1992 | K914335 | STRAP, HEAD, GAS MASK Vital Signs, Inc. | BTK |
| Mar 25, 1992 | K914336 | BREATHE EASY Vital Signs, Inc. | BYD |
| Mar 24, 1992 | K905273 | BAUMAN DISPOSABLE LARYNGOSCOPE BLADES Vital Signs, Inc. | CCW |
| Mar 20, 1992 | K915277 | ENDOTRACHEAL CPAP SET Vital Signs, Inc. | BTR |
| Mar 11, 1992 | K914337 | GAS SAMPLING INTERFACES Vital Signs, Inc. | CCK |
| Oct 18, 1991 | K911465 | INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL Vital Signs, Inc. | BZD |
| Oct 10, 1991 | K912652 | FLEX-ELBOW Vital Signs, Inc. | BZA |
| Sep 11, 1991 | K912578 | 20CM/H20 PEEP VALVE Vital Signs, Inc. | BYE |
| Aug 16, 1991 | K912650 | 1.1, 1.2, 1.3 TEMPERATURE PROBES Vital Signs, Inc. | FLL |
| Aug 2, 1991 | K912626 | BOLUS XENON CIRCUIT Vital Signs, Inc. | IYT |
| Aug 2, 1991 | K912625 | MOUTH TO MASK RESUSCITATOR Vital Signs, Inc. | BTM |
| Jul 25, 1991 | K912638 | BLOOD PRESSURE CUFFS Vital Signs, Inc. | DXQ |
| Jul 24, 1991 | K904899 | VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR Vital Signs, Inc. | BTM |
| Jul 1, 1991 | K905450 | ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE Vital Signs, Inc. | CAI |
| Jun 18, 1991 | K910856 | MANUAL RESUSCITATOR Vital Signs, Inc. | BTM |
| Apr 10, 1991 | K904830 | BACTERIA FILTER Vital Signs, Inc. | CAH |
| Jan 8, 1991 | K904874 | ADJUSTABLE PEEP VALVE Vital Signs, Inc. | BYE |
| Aug 14, 1990 | K901728 | ONE-LUNG CPAP DEVICE Vital Signs, Inc. | BYE |
| Aug 2, 1988 | K882319 | TELEMETRIC STETHOSCOPE Vital Signs, Inc. | BZT |
| Aug 25, 1986 | K861981 | ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR Vital Signs, Inc. | DRW |
| Jul 7, 1986 | K862003 | CIRCUIT ANES. BREATHING & COMPONENTS Vital Signs, Inc. | CAI |
Newest 50 of 75.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2010 | Vital Signs Inc Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids. Terminated |
LGZ | K060537 |
| Sep 8, 2009 | Vital Signs Inc 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,
INTRAOSSEU Terminated |
GAA | None listed |