510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953055Substantially Equivalent

Mistassist Breathing Exerciser

The Merlin Corp., Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953055 is the FDA 510(k) clearance record for MISTASSIST BREATHING EXERCISER, a class II device, cleared for The Merlin Corp. on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list 2 510(k) clearances for The Merlin Corp., from to . As of , FDA records show no recalls naming K953055.

Clearance record

Decision date
Received
(223 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
The Merlin Corp. 1127 Garrido Dr., Camarillo CA
510(k) summary
Statement
Third party review
No

Clearances, product code BWF

Trailing 12 months

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

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