510(k) K251448 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
FL-10000U Respiratory Humidifier
| Applicant | Flexicare Medical Limited., Rhondda Cynon Taf, GB |
| Decision | Substantially Equivalent, Jan 16, 2026 |
| Received | May 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251448
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.