# Pulmonetic Systems, Inc.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 12 (1998–2009): 12 510(k) clearances
- Product codes: CBK (12)
- Predicates its devices cite: 18 (7 its own); citations of its devices by later devices: 45 (7 its own)
- Recalls linked to its devices: 17 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bird Products Corp.: 5 (https://510kreport.com/company/bird-products)
- Versamed, Ltd.: 2 (https://510kreport.com/company/versamed)
- Datex-Ohmeda, Inc.: 1 (https://510kreport.com/company/datex-ohmeda)
- Aequitron Medical, Inc.: 1 (https://510kreport.com/company/aequitron-medical)
- Allegiance Healthcare Corp.: 1 (https://510kreport.com/company/allegiance-healthcare)
- Versamed Medical Systems, Inc.: 1 (https://510kreport.com/company/versamed-medical-systems)

## Firms that cite its devices most
- Newport Medical Instruments, Inc.: 16 (https://510kreport.com/company/newport-medical-instruments)
- Respironics California, Inc.: 2 (https://510kreport.com/company/respironics-california)
- Care Fusion: 2 (https://510kreport.com/company/care-fusion)
- Breathe Technologies, Inc.: 2 (https://510kreport.com/company/breathe-technologies)
- Draeger Medical, Inc.: 2 (https://510kreport.com/company/draeger-medical)
- Respironics Inc., Sleep & Home Respiratory Group: 2 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)
- Resmed, Ltd.: 1 (https://510kreport.com/company/resmed)
- Versamed Medical Systems, Inc.: 1 (https://510kreport.com/company/versamed-medical-systems)

## Its most-cited devices
- K060647: LTV 1200 Ventilator (2006), cited by 9
- K984056: LTV 1000 (1999), cited by 7
- K051767: LTV 1000 Ventilator (2005), cited by 6
- K981371: LTV 1000 Ventilator (1998), cited by 6
- K032226: LTV-1000 Ventilator (2003), cited by 4
- K070594: Palmtop Ventilator, Models PTV-8, PTV-10 (2007), cited by 3

## Recent decisions
- K083688: Pulmonetic Systems LTV 1200 MR Conditional Ventilator (Mar 18, 2009)
- K070594: Palmtop Ventilator, Models PTV-8, PTV-10 (Aug 1, 2007)
- K060647: LTV 1200 Ventilator (May 25, 2006)
- K060549: Automobile Lighter Power Cord (May 4, 2006)
- K051767: LTV 1000 Ventilator (Jul 29, 2005)
- K040790: Modification to LTV 1000 Ventilator/Breathing Circuits (Jun 3, 2004)
- K040540: Modification to LTV 1000 Ventilator (Apr 29, 2004)
- K032226: LTV-1000 Ventilator (Oct 16, 2003)

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