FDA applicant
Dongguan TT Medical, Inc.
FDA records 6 decisions for Dongguan TT Medical, Inc. (Dongguan, CN) from 2023 to 2026: 6 510(k) clearances. Most are in product codes OZT (Balloon Aortic Valvuloplasty) and KTI (Bronchoscope Accessory). Since 2016 its 510(k)s took a median of 188 days from receipt to decision, against 168 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 Dongguan TT Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Dongguan TT Medical, 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