Orbusneich Medical Trading, Inc.: FDA clearances and approvals
Orbusneich Medical Trading, Inc. has 7 FDA 510(k) clearances (first 2018, latest 2020), across 4 product codes in 1 review panel. Median 510(k) review time: 71 days. Since 2017 its median was 71 days, against 107 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 4 | 76 |
| 2019 | 2 | 139 |
| 2020 | 1 | 29 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Orbusneich Medical Trading, Inc.'s cleared 510(k)s took a median 71 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 4 | 4 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Orbusneich Medical Trading, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200269 | Sapphire II PRO | LOX | 2020-03-04 | 29 |
| K192344 | Sapphire NC Plus Coronary Dilatation Catheter | LOX | 2019-09-19 | 21 |
| K182713 | Scoreflex PTA Scoring Balloon Catheter | PNO | 2019-06-11 | 257 |
| K182360 | Teleport Microcatheter | DQY | 2018-11-09 | 71 |
| K180921 | Sapphire II PRO Balloon Dilatation Catheter | LOX | 2018-06-28 | 80 |
| K173680 | Sapphire II PRO | LOX | 2018-03-01 | 90 |
| K173894 | Jade PTA Balloon Dilatation Catheter | LIT | 2018-02-09 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Orbusneich Medical Trading, Inc..
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 Orbusneich Medical Trading, Inc.'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 Orbusneich Medical Trading, Inc. have?
Orbusneich Medical Trading, Inc. has 7 FDA 510(k) clearances (first 2018, latest 2020), across 4 product codes in 1 review panel.
How long does FDA take to clear Orbusneich Medical Trading, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Orbusneich Medical Trading, Inc.'s cleared 510(k)s is 71 days. Since 2017: 71 days, versus 107 days for all cleared 510(k)s in the same product codes.
What devices does Orbusneich Medical Trading, Inc. make?
Its most frequent FDA product codes are LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 4); DQY (Catheter, Percutaneous, 1); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 1).
Has Orbusneich Medical Trading, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Orbusneich Medical Trading, Inc. Related entities may recall under other names.
Next steps
- See all 7 Orbusneich Medical Trading, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LOX, Orbusneich Medical Trading, Inc.'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.