FDA product code HHM: Sound, Uterine
HHM is the FDA product code for sound, uterine. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 10 510(k) submissions under HHM, from 9 different applicants. The average 510(k) review took 73 days (median 56). FDA has posted 4 recalls for HHM devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Sound, Uterine |
| Device class | Class I |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HHM clearance
Top HHM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| A & A Medical, Inc. | 2 | 1988-12-20 |
| Cervilenz, Inc. | 1 | 2001-08-10 |
| Rocket of London, Ltd. | 1 | 1994-02-24 |
| Cook Ob/Gyn | 1 | 1987-03-04 |
| Intl. Medical Technologies, Inc. | 1 | 1984-04-30 |
4 more applicants have HHM clearances. See the full list in Caduvo.
Most recent HHM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011840 | Cervilenz, Inc. | CERVILENZ UTERINE MEASURING SOUND | 2001-08-10 | 59 |
| K935665 | Rocket of London, Ltd. | INTRAUTERINE SOUND | 1994-02-24 | 90 |
| K884684 | A & A Medical, Inc. | ROCKET INTRAUTERINE DEPTH SOUND | 1988-12-20 | 42 |
| K883806 | A & A Medical, Inc. | ROCKET INTRAUTERINE SOUND | 1988-10-31 | 54 |
| K870550 | Cook Ob/Gyn | TEFLON UTERINE SOUND | 1987-03-04 | 22 |
Recalls for HHM devices
4 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-07-31.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code HHM?
HHM is the FDA product code for sound, uterine. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHM?
Class I, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HHM?
Across 10 cleared submissions the average was 73 days from receipt to decision (median 56).
Which companies have the most HHM clearances?
A & A Medical, Inc. (2); Cervilenz, Inc. (1); Rocket of London, Ltd. (1); Cook Ob/Gyn (1); Intl. Medical Technologies, Inc. (1).
Have HHM devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2024-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code HHM
- Run a recall and safety report across every HHM manufacturer
- Watch product code HHM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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