510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934945Substantially Equivalent

Flowmeter Nipple Adaptor

Cardio Search, Inc., Dundas, Ont.L9h 5y2, Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934945 is the FDA 510(k) clearance record for FLOWMETER NIPPLE ADAPTOR, a class I device, cleared for Cardio-Search , Ltd. on under FDA product code CCN (Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge). FDA records list 5 510(k) clearances for Cardio-Search , Ltd., from to . As of , FDA records show no recalls naming K934945.

Clearance record

Decision date
Received
(35 days to decision)
Product code
CCN Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Regulation
21 CFR 868.2300
Device class
Class I
Review panel
Anesthesiology
Applicant
Cardio-Search , Ltd. 170 Old Guelph Rd., Dundas, Ont.L9h 5y2, Canada, CA
510(k) summary
Statement
Third party review
No

Clearances, product code CCN

Trailing 12 months

FDA records hold no clearances under product code CCN in the trailing twelve months.

FDA records show no clearances under product code CCN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CCN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260