510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K960411Substantially Equivalent

Microair by Invacare Model Apm Alternating Pressure Air Flotation Matress

Invacare GmbH, Elyria OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960411 is the FDA 510(k) clearance record for MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS, a class II device, cleared for Invacare Corp. on under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure). FDA records list 131 510(k) clearances for Invacare Corp., from to . As of , FDA records show no recalls naming K960411.

Clearance record

Decision date
Received
(49 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
Invacare Corp. 899 Cleveland St., Elyria OH
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FNM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260