FDA applicant
Tracoe Medical GmbH
FDA records 8 decisions for Tracoe Medical GmbH (Nieder-Olm, DE) from 1978 to 2021: 8 510(k) clearances. Most are in product codes JOH (Tube Tracheostomy And Tube Cuff) and BTO (Tube, Tracheostomy (W/Wo Connector)). Since 2016 its 510(k)s took a median of 363 days from receipt to decision, against 376 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 2 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 Tracoe Medical GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Tracoe Medical 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) Report