FDA applicant
Kossel Medtech (Suzhou) Co., Ltd.
FDA records 7 decisions for Kossel Medtech (Suzhou) Co., Ltd. (Suzhou, CN) from 2018 to 2026: 7 510(k) clearances. Most are in product codes LOX (Catheters, Transluminal Coronary Angioplasty…) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Since 2016 its 510(k)s took a median of 219 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 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 Kossel Medtech (Suzhou) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Kossel Medtech (Suzhou) Co., 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