510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K945478Substantially Equivalent

Am-50 Aerosol/medication Air Compressor

Preferred Medical Supply, Inc., Buffalo NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945478 is the FDA 510(k) clearance record for AM-50 AEROSOL/MEDICATION AIR COMPRESSOR, a class II device, cleared for Preferred Medical Supply, Inc. on under FDA product code BTI (Compressor, Air, Portable). FDA records list one 510(k) clearance for Preferred Medical Supply, Inc. As of , FDA records show no recalls naming K945478.

Clearance record

Decision date
Received
(324 days to decision)
Product code
BTI Compressor, Air, Portable
Regulation
21 CFR 868.6250
Device class
Class II
Review panel
Anesthesiology
Applicant
Preferred Medical Supply, Inc. 1574 Kenmore Ave., Buffalo NY
510(k) summary
Summary
Third party review
No

Clearances, product code BTI

Trailing 12 months

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

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