# Caldyne, Inc.

- Location (FDA's records): Temecula, CA
- FDA decisions: 1 (2005–2005): 1 510(k) clearance
- Product codes: BZK (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 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
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)
- Micro Direct, Inc.: 1 (https://510kreport.com/company/micro-direct)

## Recent decisions
- K051279: Caldyne, Inc. Exhalometer EX100, Model EX100 (Sep 7, 2005)

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