FDA applicant
Chalice Medical, Ltd.
FDA records 3 decisions for Chalice Medical, Ltd. (Worksop, GB) from 2020 to 2023: 3 510(k) clearances. All are in product code DTZ (Oxygenator, Cardiopulmonary Bypass). Since 2016 its 510(k)s took a median of 169 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Chalice Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Chalice Medical, Ltd.’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) Report