HHMClass I

Sound, Uterine

21 CFR 884.4530 / Obstetrics/Gynecology

HHM is the FDA product code for Sound, Uterine, a class I device type, regulated under 21 CFR 884.4530. As of 2026-09-10, FDA records hold 10 510(k) clearances under this code, the most recent dated 2001-08-10, and 4 recalls.

Classification record

Product code: HHM
Device name: Sound, Uterine
Regulation: 21 CFR 884.4530
Device class: Class I
Review panel: Obstetrics/Gynecology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 10
Ingested recalls: 4

Clearances, product code HHM

By decision year

10 clearances under product code HHM with a decision year between 1976 and 2001, 1988 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code HHM by decision year
Year	Clearances
1976	1
1978	1
1981	1
1983	1
1984	1
1987	1
1988	2
1994	1
2001	1

Applicants with the most clearances

Product code HHM

Applicants holding the most 510(k) clearances under product code HHM
Applicant	Clearances
A & A Medical, Inc.	2
Axcan Scientific Corp.	1
C.R. Bard Inc	1
Cervilenz, Inc.	1
Cook Ob/Gyn	1
G.D. Searle and Co.	1
Gynemetrics, Inc.	1
Intl. Medical Technologies, Inc.	1
Rocket of London, Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 128 companies shown, in name order