# Ivwatch, LLC

- Location (FDA's records): Newport News, VA
- FDA decisions: 6 (2015–2024): 6 510(k) clearances
- Product codes: PMS (5), MRZ (1)
- Predicates its devices cite: 6 (5 its own); citations of its devices by later devices: 5 (5 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
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)

## Its most-cited devices
- K162478: ivWatch (2016), cited by 2
- K153605: ivWatch Model 400 (2016), cited by 1
- K142374: ivWatch Model 400 (2015), cited by 1
- K192385: ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable (2020), cited by 1

## Recent decisions
- K233881: ivWatch® Model 400 (Mar 15, 2024)
- K222212: ivWatch Model 400 (Aug 24, 2022)
- K192385: ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable (Jul 2, 2020)
- K162478: ivWatch (Dec 22, 2016)
- K153605: ivWatch Model 400 (Feb 11, 2016)
- K142374: ivWatch Model 400 (Feb 13, 2015)

Source page: https://510kreport.com/company/ivwatch