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510(k) K040654

SENSILASE PAD 3000 by Optical Sensors, Inc. — Product Code DPW

K040654 is an FDA 510(k) premarket notification submitted by Optical Sensors, Inc. for the device "SENSILASE PAD 3000". The FDA issued a decision of Substantially Equivalent on June 4, 2004. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Optical Sensors, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2004
Date Received
March 12, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Optical Sensors, Inc.

  • K010795 — CAPNOPROBE SL, MODEL 2000 (April 11, 2001)
  • K984579 — CAPNO PROBE A (December 21, 2000)
  • K961790 — POINT-OF-CARE BLOOD GAS MONITOR SYSTEM (April 9, 1997)
  • K963935 — OLYMPUS CRITICAL CARE MONITORING SYSTEM (January 23, 1997)
  • K951094 — POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM (January 16, 1996)
  • K931185 — SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE (October 21, 1993)

Other clearances for product code DPW

  • K260700 — BlueDop Vascular Expert (July 8, 2026)
  • K252810 — FloPatch FP120 (April 24, 2026)
  • K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
  • K251114 — FloPatch FP120 (June 20, 2025)
  • K243852 — Elfor-L (April 14, 2025)
  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K223843 — FloPatch FP120 (May 3, 2023)
  • K222242 — FloPatch FP120 (December 9, 2022)
  • K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2) (April 20, 2022)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)

FDA data resources