Kossel Medtech (Suzhou) Co., Ltd.: FDA clearances and approvals
Kossel Medtech (Suzhou) Co., Ltd. has 6 FDA 510(k) clearances (first 2018, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 222 days. Since 2017 its median was 222 days, against 110 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 60 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 58 |
| 2022 | 2 | 238 |
| 2023 | 1 | 219 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 261 |
Review time against the same product codes
Since 2017, Kossel Medtech (Suzhou) Co., Ltd.'s cleared 510(k)s took a median 222 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 3 | 3 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 3 | 3 |
Review panels
- Cardiovascular (6)
Most recent Kossel Medtech (Suzhou) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254212 | NC PTA Balloon Dilatation Catheter | LIT | 2026-09-16 | 261 |
| K231402 | HP PTA Balloon Dilatation Catheter | LIT | 2023-12-20 | 219 |
| K221245 | PTA Balloon Dilatation Catheter | LIT | 2022-12-14 | 226 |
| K211349 | Selebrek PTCA Balloon Dilatation Catheter | LOX | 2022-01-07 | 249 |
| K211393 | Selethru(TM) NC PTCA Balloon Dilatation Catheter | LOX | 2021-07-02 | 58 |
| K182699 | Selethru PTCA Balloon Dilatation Catheter | LOX | 2018-11-26 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Kossel Medtech (Suzhou) Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Kossel Medtech (Suzhou) Co., Ltd.'s product codes (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Frequently asked questions
How many FDA 510(k) clearances does Kossel Medtech (Suzhou) Co., Ltd. have?
Kossel Medtech (Suzhou) Co., Ltd. has 6 FDA 510(k) clearances (first 2018, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Kossel Medtech (Suzhou) Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Kossel Medtech (Suzhou) Co., Ltd.'s cleared 510(k)s is 222 days. Since 2017: 222 days, versus 110 days for all cleared 510(k)s in the same product codes.
What devices does Kossel Medtech (Suzhou) Co., Ltd. make?
Its most frequent FDA product codes are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 3); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 3).
Has Kossel Medtech (Suzhou) Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kossel Medtech (Suzhou) Co., Ltd. Related entities may recall under other names.
Next steps
- See all 6 Kossel Medtech (Suzhou) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LIT, Kossel Medtech (Suzhou) Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.