# Orbusneich Medical Trading, Inc.

- Location (FDA's records): Fort Lauderdale, FL
- FDA decisions: 7 (2018–2020): 7 510(k) clearances
- Product codes: LOX (4), PNO (1), DQY (1), LIT (1)
- 510(k) review time since 2016: median 76 days, against 93 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 9 (1 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, Inc.: 2 (https://510kreport.com/company/orbusneich-medical)
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Bard Peripheral Vascular, Inc.: 1 (https://510kreport.com/company/bard-peripheral-vascular)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)
- Abbott Vascular: 1 (https://510kreport.com/company/abbott-vascular)
- Medtronic, Ireland: 1 (https://510kreport.com/company/medtronic-ireland)

## Firms that cite its devices most
- OrbusNeich Medical (Shenzhen) Co., Ltd.: 5 (https://510kreport.com/company/orbusneich-medical-shenzhen)
- Terumo Corp.: 1 (https://510kreport.com/company/terumo)
- Medcaptain Life Science Co., Ltd.: 1 (https://510kreport.com/company/medcaptain-life-science)
- Kossel Medtech (Suzhou) Co., Ltd.: 1 (https://510kreport.com/company/kossel-medtech-suzhou)

## Its most-cited devices
- K180921: Sapphire II PRO Balloon Dilatation Catheter (2018), cited by 3
- K192344: Sapphire NC Plus Coronary Dilatation Catheter (2019), cited by 2
- K173894: Jade PTA Balloon Dilatation Catheter (2018), cited by 2
- K182360: Teleport Microcatheter (2018), cited by 1
- K173680: Sapphire II PRO (2018), cited by 1

## Recent decisions
- K200269: Sapphire II PRO (Mar 4, 2020)
- K192344: Sapphire NC Plus Coronary Dilatation Catheter (Sep 19, 2019)
- K182713: Scoreflex PTA Scoring Balloon Catheter (Jun 11, 2019)
- K182360: Teleport Microcatheter (Nov 9, 2018)
- K180921: Sapphire II PRO Balloon Dilatation Catheter (Jun 28, 2018)
- K173680: Sapphire II PRO (Mar 1, 2018)
- K173894: Jade PTA Balloon Dilatation Catheter (Feb 9, 2018)

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