# Level 1 Technologies, Inc.

- Location (FDA's records): Rockland, MA
- FDA decisions: 5 (1987–1996): 5 510(k) clearances
- Product codes: LGZ (1), GCY (1), KOD (1), CAC (1), FPA (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Estill Medical Technologies, Inc.: 2 (https://510kreport.com/company/estill-medical-technologies)
- Smiths Medical Asd, Inc.: 2 (https://510kreport.com/company/smiths-medical-asd)
- Arizant Healthcare, Inc.: 1 (https://510kreport.com/company/arizant-healthcare)
- Haemonetics Corp.: 1 (https://510kreport.com/company/haemonetics)

## Its most-cited devices
- K911383: Hotline Fluid Warmer (1991), cited by 2
- K873435: Level 1 IR-600 Normothermic Irrigating Set (1987), cited by 2
- K936223: Pressure Irrigating System (1994), cited by 1
- K942844: Level 1 Blood Stream Recovery System (1996), cited by 1

## Recent decisions
- K942844: Level 1 Blood Stream Recovery System (Apr 26, 1996)
- K942271: Level 1* Inject Needle-Free Injection Site (Jul 12, 1995)
- K936223: Pressure Irrigating System (May 12, 1994)
- K911383: Hotline Fluid Warmer (Oct 17, 1991)
- K873435: Level 1 IR-600 Normothermic Irrigating Set (Oct 5, 1987)

Source page: https://510kreport.com/company/level-1-technologies