FNMClass II

Mattress, Air Flotation, Alternating Pressure

21 CFR 880.5550 / General Hospital

FNM is the FDA product code for Mattress, Air Flotation, Alternating Pressure, a class II device type, regulated under 21 CFR 880.5550. As of 2026-09-10, FDA records hold 102 510(k) clearances under this code, the most recent dated 1998-02-20, and 13 recalls.

Classification record

Product code: FNM
Device name: Mattress, Air Flotation, Alternating Pressure
Regulation: 21 CFR 880.5550
Device class: Class II
Review panel: General Hospital
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 102
Ingested recalls: 13

Clearances, product code FNM

By decision year

102 clearances under product code FNM with a decision year between 1976 and 1998, 1995 the highest year at 17.

Show the numbers

510(k) clearances under FDA product code FNM by decision year
Year	Clearances
1976	1
1977	1
1978	3
1979	1
1980	1
1981	3
1984	1
1985	4
1986	1
1987	3
1988	6
1989	3
1990	4
1992	4
1993	8
1994	9
1995	17
1996	14
1997	14
1998	4

Applicants with the most clearances

Product code FNM

Applicants holding the most 510(k) clearances under product code FNM
Applicant	Clearances
KCI USA, Inc.	8
Span-America Medical Systems, Inc.	8
Huntleigh Technology, Inc.	5
9th Wave, Inc.	3
Gaymar Industries, Inc.	3
Lumex, Inc.	3
Pegasus Airwave, Inc.	3
Plexus Medical	3
Bio Clinic Co.	2
Ch Administration, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 125 companies shown, in name order