IKYClass I

Mattress, Flotation Therapy, Non-Powered

21 CFR 880.5150 / General Hospital

IKY is the FDA product code for Mattress, Flotation Therapy, Non-Powered, a class I device type, regulated under 21 CFR 880.5150. As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 1992-03-12, and 11 recalls.

Classification record

Product code: IKY
Device name: Mattress, Flotation Therapy, Non-Powered
Regulation: 21 CFR 880.5150
Device class: Class I
Review panel: General Hospital
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 8
Ingested recalls: 11

Clearances, product code IKY

By decision year

8 clearances under product code IKY with a decision year between 1976 and 1992, 1977 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code IKY by decision year
Year	Clearances
1976	1
1977	2
1978	1
1980	2
1981	1
1992	1

Applicants with the most clearances

Product code IKY

Applicants holding the most 510(k) clearances under product code IKY
Applicant	Clearances
Jefferson Industries, Inc.	2
Medpro, Inc.	2
Arco Medical Products Co.	1
Gaymar Industries, Inc.	1
Leemart Bedding Mfg. Co.	1
Tetra Group U.S.A., Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 149 companies shown, in name order