510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140113Substantially Equivalent

O2 Nasal Cannula with CO2 Monitoring

Flexicare Medical Ltd., Mid Glamorgan, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140113 is the FDA 510(k) clearance record for O2 NASAL CANNULA WITH CO2 MONITORING, a class II device, cleared for Flexicare Medical, Ltd. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 15 510(k) clearances for Flexicare Medical, Ltd., from to . As of , FDA records show no recalls naming K140113.

Clearance record

Decision date
Received
(50 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
Flexicare Medical, Ltd. Cynon Valley Business Park, Mid Glamorgan, GB
510(k) summary
Summary PDF
Third party review
Yes

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