# Broncus Medical, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 7 (2013–2026): 7 510(k) clearances
- Product codes: EOQ (4), LLZ (2), GEI (1)
- 510(k) review time since 2016: median 277 days, against 130 for FDA's reviews in the same codes and years (0 of 5 faster)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 5 (3 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
- Broncus Technologies, Inc.: 3 (https://510kreport.com/company/broncus-technologies)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)
- Philips Medical Systems North America, Inc.: 1 (https://510kreport.com/company/philips-medical-systems-north-america)
- Medtronic Advanced Energy: 1 (https://510kreport.com/company/medtronic-advanced-energy)
- Covidien: 1 (https://510kreport.com/company/covidien)

## Firms that cite its devices most
- Sanovas, Inc.: 1 (https://510kreport.com/company/sanovas)
- Covidien: 1 (https://510kreport.com/company/covidien)

## Its most-cited devices
- K131234: Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon) (2013), cited by 4
- K183240: Empower RF Catheter (2019), cited by 1

## Recent decisions
- K260009: LungPoint Virtual Bronchoscopic Navigation (VBN) Software (Apr 24, 2026)
- K232601: BroncTru™ Transbronchial Access Tool (May 31, 2024)
- K232038: BioStar Single Use Transbronchial Aspiration Needle (Apr 26, 2024)
- K200702: EasyPath RF Introducer Sheath (Jan 14, 2021)
- K183240: Empower RF Catheter (Feb 22, 2019)
- K133385: Lungpoint Atv Planning and Navigation Software (Feb 26, 2014)
- K131234: Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon) (Oct 15, 2013)

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