FDA applicant
Maquet GmbH
FDA records 8 decisions for Maquet GmbH (Rastatt, DE) from 2004 to 2022: 8 510(k) clearances. Most are in product codes FLE (Sterilizer, Steam) and CAH (Filter, Bacterial, Breathing-Circuit). Since 2016 its 510(k)s took a median of 196 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 5 of them its own earlier devices. 22 recalls are linked to its devices.
FDA’s records also spell it “Maquet S.A.S.”, “Maquet, Inc.”, “Maquet S.A.”, “Maquet GmbH and Co. KG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Maquet GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Maquet GmbH’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 “Maquet”
FDA records each applicant name separately; these may or may not be the same firm.