# International Respiratory Systems, Inc.

- Location (FDA's records): Crofton, MD
- FDA decisions: 3 (1992–1998): 3 510(k) clearances
- Product codes: BTM (2), BYE (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K981307: International Respiratory Systems, Inc.'S Manual Resusciator (Jul 6, 1998)
- K981308: International Respiratory Systems, Inc.'S Manual Pulmonary Resuscitator with Rubber Compression Bag (Jul 6, 1998)
- K923618: Peep Valve (Aug 3, 1992)

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