FDA applicant
Huntleigh Healthcare, Inc.
FDA records 27 decisions for Huntleigh Healthcare, Inc. (Cardiff, GB) from 1993 to 2025: 27 510(k) clearances. Most are in product codes HGM (System, Monitoring, Perinatal) and JOW (Sleeve, Limb, Compressible). Since 2016 its 510(k)s took a median of 250 days from receipt to decision, against 154 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 9 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Huntleigh Healthcare , Ltd.”, “Huntleigh Healthcare Limited”, “Huntleigh Healthcare”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Huntleigh Healthcare, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Huntleigh Healthcare, Inc.’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 “Huntleigh”
FDA records each applicant name separately; these may or may not be the same firm.