510(k) Report

FDA applicant

Opsens, Inc.

Quebec, CA11 decisions2015–20260 recalls

FDA records 11 decisions for Opsens, Inc. (Quebec, CA) from 2015 to 2026: 11 510(k) clearances. Most are in product codes DXO (Transducer, Pressure, Catheter Tip) and DQX (Wire, Guide, Catheter). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 12 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Opsens”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Opsens, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015: 12016: 22019: 12020: 32022: 12024: 12025: 12026 (partial year): 1
2015high 3 (2020) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Opsens, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Opsens, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXOTransducer, Pressure, Catheter Tip6decisions
  • DQXWire, Guide, Catheter5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 121 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 20 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 12 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K142598Opto Wire and OptoMonitor SystemOpsens, Inc. · 20154cite it
  • K213854SavvyWireOpsens, Inc. · 20223cite it
  • K192340OptoMonitorOpsens, Inc. · 20192cite it
  • K152991OptoWire DeuxOpsens · 20161cites it
  • K202943OptoMonitor 3Opsens, Inc. · 20201cites it
  • K191907OptoWire IIIOpsens, Inc. · 20201cites it

What has FDA decided for it lately?

  • K251367OptoMonitor 3Opsens, Inc. · 2026
  • K241418OptoMonitor 3Opsens, Inc. · 2025
  • K240864PacePro WireOpsens, Inc. · 2024
  • K213854SavvyWireOpsens, Inc. · 2022
  • K202943OptoMonitor 3Opsens, Inc. · 2020
  • K193620OptoMonitor 3Opsens, Inc. · 2020
  • K191907OptoWire IIIOpsens, Inc. · 2020
  • K192340OptoMonitorOpsens, Inc. · 2019

All 10 as Opsens, Inc. →The one decision as Opsens →