OrbusNeich Medical (Shenzhen) Co., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “OrbusNeich Medical (Shenzhen) Co., Ltd.” (first 2020, latest 2026), plus 1 PMA decision, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 128 days. Since 2017 the median was 128 days, against 107 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 2 | 76 |
| 2021 | 1 | 125 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 4 | 254 |
| 2025 | 1 | 130 |
| 2026 | 2 | 151 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name OrbusNeich Medical (Shenzhen) Co., Ltd. took a median 128 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 3 | 3 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 3 | 3 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 3 | 3 |
| NWX | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring | 1 | 0 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 1 | 1 |
Review panels
- Cardiovascular (11)
Most recent OrbusNeich Medical (Shenzhen) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261778 | JADE SCORE PTA Scoring Balloon Dilatation Catheter | PNO | 2026-09-16 | 110 |
| K253361 | Teleport Glide Microcatheter | DQY | 2026-04-10 | 192 |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | DQY | 2025-01-07 | 130 |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | LOX | 2024-08-16 | 290 |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | LOX | 2024-08-15 | 289 |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | LIT | 2024-06-11 | 57 |
| K231608 | Teleport XT Microcatheter | DQY | 2024-01-07 | 219 |
| K211807 | Sapphire NC 24 | LOX | 2021-10-14 | 125 |
| K202231 | JADE | LIT | 2020-12-10 | 125 |
| K201794 | Jade | LIT | 2020-07-28 | 28 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200041 | PMA | Scoreflex NC Scoring PTCA Catheter | 2021-12-21 |
Recalls
openFDA lists no recalls under a recalling firm named OrbusNeich Medical (Shenzhen) Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under OrbusNeich Medical (Shenzhen) Co., Ltd. (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)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Orbusneich Medical Trading, Inc. (7 510(k)s)
- Orbusneich Medical, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under OrbusNeich Medical (Shenzhen) Co., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “OrbusNeich Medical (Shenzhen) Co., Ltd.” (first 2020, latest 2026), plus 1 PMA decision, across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by OrbusNeich Medical (Shenzhen) Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name OrbusNeich Medical (Shenzhen) Co., Ltd. is 128 days. Since 2017: 128 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under OrbusNeich Medical (Shenzhen) Co., Ltd.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 3); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 3); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 3).
Next steps
- See all 10 OrbusNeich Medical (Shenzhen) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQY, OrbusNeich Medical (Shenzhen) Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.