510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K944412Substantially Equivalent

The Breather

Pal Medical, Inc., Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944412 is the FDA 510(k) clearance record for THE BREATHER, a class II device, cleared for Pal Medical, Inc. on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list one 510(k) clearance for Pal Medical, Inc. As of , FDA records show no recalls naming K944412.

Clearance record

Decision date
Received
(230 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Pal Medical, Inc. 2012 1/2 Curry Ford Rd., Orlando FL
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