FDA applicant
Flexicare Medical Limited.
FDA records 16 decisions for Flexicare Medical Limited. (Mountain Ash, GB) from 1995 to 2026: 16 510(k) clearances. Most are in product codes CAH (Filter, Bacterial, Breathing-Circuit) and BTT (Humidifier, Respiratory Gas, (Direct Patient…). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 206 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.
FDA’s records also spell it “Flexicare Medical, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Flexicare Medical Limited.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Flexicare Medical Limited.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Flexicare”
FDA records each applicant name separately; these may or may not be the same firm.