510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161314Substantially Equivalent

Flexicare Fl-9000U Respiratory Humidifier Base

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

K161314 is the FDA 510(k) clearance record for FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE, a class II device, cleared for Flexicare Medical Limited. on under FDA product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). FDA records list 15 510(k) clearances for Flexicare Medical Limited., from to . As of , FDA records show no recalls naming K161314.

Clearance record

Decision date
Received
(56 days to decision)
Product code
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation
21 CFR 868.5450
Device class
Class II
Review panel
Anesthesiology
Applicant
Flexicare Medical Limited. Cynon Valley Business Park, Mountain Ash, GB
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code BTT

Trailing 12 months
5 clearances under product code BTT in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BTT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260