FDA applicant
Syncro Medical Innovations, Inc.
FDA records 6 decisions for Syncro Medical Innovations, Inc. (Macon, GA) from 2002 to 2020: 6 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and PIF (Gastrointestinal Tubes With Enteral Specific…). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 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 Syncro Medical Innovations, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Syncro Medical Innovations, 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) Report