510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K010795Substantially Equivalent

Capnoprobe Sl, Model 2000

Optical Sensors, Inc., Stoughton WI / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010795 is the FDA 510(k) clearance record for CAPNOPROBE SL, MODEL 2000, a class II device, cleared for Optical Sensors, Inc. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 7 510(k) clearances for Optical Sensors, Inc., from to . As of , FDA records show one recall naming K010795.

Clearance record

Decision date
Received
(26 days to decision)
Product code
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation
21 CFR 868.1400
Device class
Class II
Review panel
Anesthesiology
Applicant
Optical Sensors, Inc. 800 Lenanger Ln., Stoughton WI
510(k) summary
Summary
Third party review
No

Clearances, product code CCK

Trailing 12 months
3 clearances under product code CCK in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20261
September 20260
October 20260