510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951652Substantially Equivalent

Ventimask Mk IV

Flexicare Medical Ltd., Somerset, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951652 is the FDA 510(k) clearance record for VENTIMASK MK IV, a class I device, cleared for Flexicare Medical, Ltd. on under FDA product code BYF (Mask, Oxygen, Low Concentration, Venturi). FDA records list 15 510(k) clearances for Flexicare Medical, Ltd., from to . As of , FDA records show no recalls naming K951652.

Clearance record

Decision date
Received
(17 days to decision)
Product code
BYF Mask, Oxygen, Low Concentration, Venturi
Regulation
21 CFR 868.5600
Device class
Class I
Review panel
Anesthesiology
Applicant
Flexicare Medical, Ltd. East Quay, Bridgwater, Somerset, GB
510(k) summary
Statement
Third party review
No

Clearances, product code BYF

Trailing 12 months

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

FDA records show no clearances under product code BYF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYF, 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