510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163300Substantially Equivalent

ThermoShield HME Filter

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

K163300 is the FDA 510(k) clearance record for ThermoShield HME Filter, a class II device, cleared for Flexicare Medical Limited. on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 15 510(k) clearances for Flexicare Medical Limited., from to . As of , FDA records show no recalls naming K163300.

Clearance record

Decision date
Received
(120 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
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 CAH

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