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510(k) K251367

OptoMonitor 3 by Opsens, Inc. — Product Code DXO

K251367 is an FDA 510(k) premarket notification submitted by Opsens, Inc. for the device "OptoMonitor 3". The FDA issued a decision of Substantially Equivalent on January 16, 2026. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Opsens, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2026
Date Received
May 1, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type

Other clearances by Opsens, Inc.

  • K241418 — OptoMonitor 3 (February 12, 2025)
  • K240864 — PacePro Wire (May 24, 2024)
  • K213854 — SavvyWire (September 14, 2022)
  • K202943 — OptoMonitor 3 (November 24, 2020)
  • K193620 — OptoMonitor 3 (June 18, 2020)
  • K191907 — OptoWire III (January 2, 2020)
  • K192340 — OptoMonitor (December 12, 2019)
  • K161263 — OptoMonitor II (September 13, 2016)
  • K152991 — OptoWire Deux (February 11, 2016)
  • K142598 — Opto Wire and OptoMonitor System (June 12, 2015)

Other clearances for product code DXO

  • K241418 — OptoMonitor 3 (February 12, 2025)
  • K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (July 17, 2024)
  • K222216 — TruWave Disposable Pressure Transducer (December 22, 2022)
  • K202943 — OptoMonitor 3 (November 24, 2020)
  • K193620 — OptoMonitor 3 (June 18, 2020)
  • K193279 — Comet II Pressure Guidewire (December 23, 2019)
  • K192340 — OptoMonitor (December 12, 2019)
  • K190852 — Zurich Pressure Guidewire System Model 100 (August 14, 2019)
  • K183413 — TruWave Disposable Pressure Transducer (May 1, 2019)
  • K180558 — PressureWire X (March 28, 2018)

FDA data resources