# OrbusNeich Medical (Shenzhen) Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 11 (2020–2026): 10 510(k) clearances and 1 original PMA approval
- Product codes: DQY (3), LIT (3), LOX (3), NWX (1), PNO (1)
- 510(k) review time since 2016: median 128 days, against 120 for FDA's reviews in the same codes and years (2 of 10 faster)
- Predicates its devices cite: 14 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Orbusneich Medical Trading, Inc.: 5 (https://510kreport.com/company/orbusneich-medical-trading)
- Terumo Medical Corp.: 2 (https://510kreport.com/company/terumo-medical)
- Terumo Corp.: 1 (https://510kreport.com/company/terumo)
- Orbusneich Medical, Inc.: 1 (https://510kreport.com/company/orbusneich-medical)
- Bard Peripheral Vascular, Inc.: 1 (https://510kreport.com/company/bard-peripheral-vascular)

## Its most-cited devices
- K201794: Jade (2020), cited by 1
- K231608: Teleport XT Microcatheter (2024), cited by 1
- K211807: Sapphire NC 24 (2021), cited by 1
- K202231: JADE (2020), cited by 1

## Recent decisions
- K261778: JADE SCORE PTA Scoring Balloon Dilatation Catheter (Sep 16, 2026)
- K253361: Teleport Glide Microcatheter (Apr 10, 2026)
- K242588: COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) (Jan 7, 2025)
- K233499: Sapphire NC ULTRA Coronary Dilatation Catheter (Aug 16, 2024)
- K233505: Sapphire ULTRA Coronary Dilatation Catheter (Aug 15, 2024)
- K241025: JADE PLUS PTA Balloon Dilatation Catheter (Jun 11, 2024)
- K231608: Teleport XT Microcatheter (Jan 7, 2024)
- P200041: Scoreflex NC Scoring PTCA Catheter (Dec 21, 2021)

Source page: https://510kreport.com/company/orbusneich-medical-shenzhen