510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933965Substantially Equivalent

Apex Medical Air Pumps

Apex Medical, Inc., Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933965 is the FDA 510(k) clearance record for APEX MEDICAL AIR PUMPS, a class II device, cleared for Apex Medical, Inc. on under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure). FDA records list 36 510(k) clearances for Apex Medical, Inc., from to . As of , FDA records show no recalls naming K933965.

Clearance record

Decision date
Received
(213 days to decision)
Product code
FNM Mattress, Air Flotation, Alternating Pressure
Regulation
21 CFR 880.5550
Device class
Class II
Review panel
General Hospital
Applicant
Apex Medical, Inc. East Tower, Suite 600, Santa Monica CA
510(k) summary
Statement
Third party review
No

Clearances, product code FNM

Trailing 12 months

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

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