FDA applicant
Natec Medical, Ltd.
FDA records 12 decisions for Natec Medical, Ltd. (Reduit, MU) from 2011 to 2025: 12 510(k) clearances. Most are in product codes LIT (Catheter, Angioplasty, Peripheral, Transluminal) and LOX (Catheters, Transluminal Coronary Angioplasty…). Since 2016 its 510(k)s took a median of 182 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Natec Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Natec Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2016
Class I Class II/III not classified
Planning a device like Natec 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