# Vital Signs, Inc.

- Location (FDA's records): Totowa, NJ
- FDA decisions: 75 (1979–2012): 75 510(k) clearances
- Product codes: BTM (6), BYE (6), CAI (5), CAH (5), BTR (4), BZD (4), FLL (3), DXQ (3), BYD (3), BSJ (3), CAP (2), FOZ (2)
- Predicates its devices cite: 14 (2 its own); citations of its devices by later devices: 24 (2 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Resmed, Ltd.: 4 (https://510kreport.com/company/resmed)
- Engineered Medical Systems: 1 (https://510kreport.com/company/engineered-medical-systems)
- Enginivity, LLC: 1 (https://510kreport.com/company/enginivity)
- Nellcor Puritan Bennett France Dvpt.: 1 (https://510kreport.com/company/nellcor-puritan-bennett-france-dvpt)
- Sleepnet Corporation: 1 (https://510kreport.com/company/sleepnet)
- Hammer-Plane, Inc.: 1 (https://510kreport.com/company/hammer-plane)
- Devon Industries, Inc.: 1 (https://510kreport.com/company/devon-industries)
- Pymah Corp.: 1 (https://510kreport.com/company/pymah)

## Firms that cite its devices most
- Breas Medical AB: 4 (https://510kreport.com/company/breas-medical)
- Caradyne, Ltd.: 3 (https://510kreport.com/company/caradyne)
- Vygon Corp.: 2 (https://510kreport.com/company/vygon)
- Mequ A/S: 1 (https://510kreport.com/company/mequ-a-s)
- Aeiomed, Inc.: 1 (https://510kreport.com/company/aeiomed)
- Quality IN Flow, Ltd.: 1 (https://510kreport.com/company/quality-in-flow)
- Hudson Respiratory Care, Inc.: 1 (https://510kreport.com/company/hudson-respiratory-care)
- Engineered Medical Systems: 1 (https://510kreport.com/company/engineered-medical-systems)

## Its most-cited devices
- K112902: Enflow IV Fluid Warmer (2012), cited by 5
- K030985: Breas PV 10I Cpap System, Model PV 10I (2003), cited by 3
- K952645: Vital Signs Saline Vascular Access Flush Device (1995), cited by 2
- K831503: Downs Adjustable Flow Generator (1983), cited by 2
- K002454: Breas HA50 Humidifier, Model HA50 (2001), cited by 2
- K945455: General Anesthesia System (1994), cited by 1

## Recent decisions
- K112902: Enflow IV Fluid Warmer (Mar 14, 2012)
- K041309: Imask TM (Jun 30, 2004)
- K030985: Breas PV 10I Cpap System, Model PV 10I (Oct 15, 2003)
- K022402: Disposable Pressure Manometer (Aug 22, 2002)
- K021315: Sure-Lok (Aug 21, 2002)
- K002454: Breas HA50 Humidifier, Model HA50 (Mar 7, 2001)
- K001553: Breas PV 100 Cpap System (Aug 3, 2000)
- K000441: Bodyguard (Apr 11, 2000)

Source page: https://510kreport.com/company/vital-signs