# ZetrOZ Systems, LLC

- Location (FDA's records): Trumbull, CT
- FDA decisions: 5 (2020–2026): 5 510(k) clearances
- Product codes: PFW (5)
- Predicates its devices cite: 5 (4 its own); citations of its devices by later devices: 6 (4 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
- Zetroz, Inc.: 1 (https://510kreport.com/company/zetroz)

## Firms that cite its devices most
- Manamed, Inc.: 1 (https://510kreport.com/company/manamed)
- Jkh Health Co., Ltd.: 1 (https://510kreport.com/company/jkh-health)

## Its most-cited devices
- K191568: sam 2.0 Long Duration Ultrasound System (2020), cited by 4
- K211513: sam X1 Long Duration Ultrasound Device (2021), cited by 1
- K223019: sam 2.0 Long Ultrasound Device (2023), cited by 1

## Recent decisions
- K260076: SAM 3.0 Multi-Hour Continuous Ultrasound Device (Apr 28, 2026)
- K233210: sam CS Long Duration Ultrasound Device (Oct 25, 2023)
- K223019: sam 2.0 Long Ultrasound Device (Jun 23, 2023)
- K211513: sam X1 Long Duration Ultrasound Device (Aug 18, 2021)
- K191568: sam 2.0 Long Duration Ultrasound System (Mar 6, 2020)

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