KMEClass I

Bedding, Disposable, Medical

21 CFR 880.6060 / General Hospital

KME is the FDA product code for Bedding, Disposable, Medical, a class I device type, regulated under 21 CFR 880.6060. As of 2026-09-10, FDA records hold 65 510(k) clearances under this code, the most recent dated 2004-09-17, and 2 recalls.

Classification record

Product code: KME
Device name: Bedding, Disposable, Medical
Regulation: 21 CFR 880.6060
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: 65
Ingested recalls: 2

Clearances, product code KME

By decision year

65 clearances under product code KME with a decision year between 1976 and 2004, 1984 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code KME by decision year
Year	Clearances
1976	2
1977	1
1978	4
1979	3
1980	4
1981	4
1982	4
1984	8
1985	5
1986	3
1987	4
1988	4
1989	2
1990	6
1991	5
1992	2
1993	1
1994	2
2004	1

Applicants with the most clearances

Product code KME

Applicants holding the most 510(k) clearances under product code KME
Applicant	Clearances
Sancella, Inc.	4
Haz-Med, Inc.	3
Kimberly-Clark Corporation	3
Procter & Gamble Mfg. Co.	3
Abco Dealers, Inc.	2
American Threshold Industries, Inc.	2
Anago, Inc.	2
Bio D Corp.	2
Biological & Environmental Control Laboratories	2
East Texas Lighthouse for the Blind	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 567 companies shown, in name order