# Newport Medical Instruments, Inc.

- Location (FDA's records): Costa Mesa, CA
- FDA decisions: 23 (1982–2012): 23 510(k) clearances
- Names in FDA's records: Newport Medical Instruments, Inc. (22); Newport Medical Instruments (1)
- Product codes: CBK (17), BTI (1), CAF (1), MOD (1), BZK (1), BZR (1)
- Predicates its devices cite: 51 (13 its own); citations of its devices by later devices: 18 (13 its own)
- Recalls linked to its devices: 14 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pulmonetic Systems, Inc.: 16 (https://510kreport.com/company/pulmonetic-systems)
- Versamed Medical Systems, Inc.: 10 (https://510kreport.com/company/versamed-medical-systems)
- Versamed, Ltd.: 6 (https://510kreport.com/company/versamed)
- Bird Products Corp.: 1 (https://510kreport.com/company/bird-products)
- Pacesetter, Inc.: 1 (https://510kreport.com/company/pacesetter)
- Puritan-Bennett Ireland, Ltd.: 1 (https://510kreport.com/company/puritan-bennett-ireland)
- Drager Medical AG & Co. Kgaa: 1 (https://510kreport.com/company/drager-medical-ag-co-kgaa)
- Maquet Critical Care AB: 1 (https://510kreport.com/company/maquet-critical-care)

## Firms that cite its devices most
- Ekom S.R.O.: 2 (https://510kreport.com/company/ekom)
- Flight Medical, Ltd.: 2 (https://510kreport.com/company/flight-medical)
- Respironics Inc., Sleep & Home Respiratory Group: 1 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)

## Its most-cited devices
- K992133: Newport HT50 Ventilator with Humidifier HT50-H, Newport HT50 Ventilator Without Humidifier, HT50-H1, Newport HT50 Ventil (2000), cited by 4
- K030780: Newport E500 Wave Ventilator (2004), cited by 3
- K041406: Newport C250 Air Compressor Model C250 (2004), cited by 2
- K090888: Newport HT70 Family of Ventilators (2009), cited by 2
- K082724: Newport HTS50 Ventilator with Dual Pac Battery System (2008), cited by 2
- K053502: Newport E360 Ventilator (2006), cited by 2

## Recent decisions
- K121891: Newport Aura Ventilator (Nov 9, 2012)
- K111146: Newport HT70 Ventilator (Dec 1, 2011)
- K101803: Newport E360 Ventilator (Sep 8, 2010)
- K090888: Newport HT70 Family of Ventilators (Nov 18, 2009)
- K082724: Newport HTS50 Ventilator with Dual Pac Battery System (Dec 16, 2008)
- K061094: Newport E500 Wave Ventilator (Jul 28, 2006)
- K053502: Newport E360 Ventilator (Jan 10, 2006)
- K041406: Newport C250 Air Compressor Model C250 (Dec 15, 2004)

Source page: https://510kreport.com/company/newport-medical-instruments