# Versamed Medical Systems, Inc.

- Location (FDA's records): Pearl River, NY
- FDA decisions: 8 (2004–2012): 8 510(k) clearances
- Names in FDA's records: Versamed Medical Systems, Inc. (6); Versamed Medical Systems , Ltd. (2)
- Product codes: CBK (8)
- Predicates its devices cite: 15 (6 its own); citations of its devices by later devices: 24 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bird Products Corp.: 2 (https://510kreport.com/company/bird-products)
- Versamed, Ltd.: 2 (https://510kreport.com/company/versamed)
- Respironics Inc., Sleep & Home Respiratory Group: 1 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)
- Pulmonetic Systems, Inc.: 1 (https://510kreport.com/company/pulmonetic-systems)
- Respironics California, Inc.: 1 (https://510kreport.com/company/respironics-california)
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)
- Maquet Critical Care AB: 1 (https://510kreport.com/company/maquet-critical-care)

## Firms that cite its devices most
- Newport Medical Instruments, Inc.: 10 (https://510kreport.com/company/newport-medical-instruments)
- Draeger Medical, Inc.: 1 (https://510kreport.com/company/draeger-medical)
- Maquet Critical Care AB: 1 (https://510kreport.com/company/maquet-critical-care)
- Drager Medical B.V.: 1 (https://510kreport.com/company/drager-medical)
- Pulmonetic Systems, Inc.: 1 (https://510kreport.com/company/pulmonetic-systems)
- Impact Instrumentation, Inc.: 1 (https://510kreport.com/company/impact-instrumentation)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)
- Ge Healthcare, Breas Medical AB: 1 (https://510kreport.com/company/ge-healthcare-breas-medical)

## Its most-cited devices
- K061627: Modification to I Vent 201 (2006), cited by 7
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), cited by 5
- K042468: Ivent 201 Portable Ventilator (2004), cited by 4
- K053270: IVENT 201 (2006), cited by 3
- K073694: Ivent 2001 Mri Conditional (2008), cited by 3
- K112754: IVENT101 (2012), cited by 1

## Recent decisions
- K112754: IVENT101 (Jun 15, 2012)
- K092135: Modification to Ivent 101 (Nov 23, 2009)
- K081845: IVENT101 (Mar 16, 2009)
- K073694: Ivent 2001 Mri Conditional (May 30, 2008)
- K061627: Modification to I Vent 201 (Jun 29, 2006)
- K053270: IVENT 201 (Jan 27, 2006)
- K052554: Modification to: Ivent 201 Portable Ventilator (Sep 23, 2005)
- K042468: Ivent 201 Portable Ventilator (Nov 17, 2004)

Source page: https://510kreport.com/company/versamed-medical-systems