# Opsens, Inc.

- Location (FDA's records): Quebec, CA
- FDA decisions: 11 (2015–2026): 11 510(k) clearances
- Names in FDA's records: Opsens, Inc. (10); Opsens (1)
- Product codes: DXO (6), DQX (5)
- 510(k) review time since 2016: median 121 days, against 134 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 20 (12 its own); citations of its devices by later devices: 14 (12 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
- Volcano Corporation: 3 (https://510kreport.com/company/volcano)
- Volcano Therapeutics, Inc.: 3 (https://510kreport.com/company/volcano-therapeutics)
- Lake Region Medical: 1 (https://510kreport.com/company/lake-region-medical)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)

## Firms that cite its devices most
- Solo Pace, Inc.: 1 (https://510kreport.com/company/solo-pace)
- Beijing Bywave Sensing Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/beijing-bywave-sensing-medical-technology)

## Its most-cited devices
- K142598: Opto Wire and OptoMonitor System (2015), cited by 4
- K213854: SavvyWire (2022), cited by 3
- K192340: OptoMonitor (2019), cited by 2
- K152991: OptoWire Deux (2016), cited by 1
- K202943: OptoMonitor 3 (2020), cited by 1
- K191907: OptoWire III (2020), cited by 1

## Recent decisions
- K251367: OptoMonitor 3 (Jan 16, 2026)
- K241418: OptoMonitor 3 (Feb 12, 2025)
- K240864: PacePro Wire (May 24, 2024)
- K213854: SavvyWire (Sep 14, 2022)
- K202943: OptoMonitor 3 (Nov 24, 2020)
- K193620: OptoMonitor 3 (Jun 18, 2020)
- K191907: OptoWire III (Jan 2, 2020)
- K192340: OptoMonitor (Dec 12, 2019)

Source page: https://510kreport.com/company/opsens