FDA product code HHI: System, Abortion, Vacuum
HHI is the FDA product code for system, abortion, vacuum. It is a Class II device, regulated under 21 CFR 884.5070 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 24 510(k) submissions under HHI, from 18 different applicants. The average 510(k) review took 73 days (median 56). FDA has posted 2 recalls for HHI devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Abortion, Vacuum |
| Device class | Class II |
| Regulation | 21 CFR 884.5070 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HHI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 136 |
Compare with all 510(k) review times · Search every HHI clearance
Top HHI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intl. Medical Technologies, Inc. | 4 | 1984-04-30 |
| Cosmedtech, Inc. | 3 | 1987-11-25 |
| Williams Specialty Products, Inc. | 2 | 1990-03-30 |
| Gyrus Acmi | 1 | 2017-09-29 |
| Acmi Corporation | 1 | 2003-06-23 |
13 more applicants have HHI clearances. See the full list in Caduvo.
Most recent HHI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171440 | Gyrus Acmi | Berkeley VC-10 Vacuum Curettage System | 2017-09-29 | 136 |
| K030935 | Acmi Corporation | BERKELEY V-10 VACUUM CURETTAGE SYSTEM | 2003-06-23 | 90 |
| K983181 | Cytoprep Inc. Est. | CYTOPREP | 1998-11-16 | 66 |
| K931205 | Baxter Healthcare Corp | MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER | 1994-03-15 | 371 |
| K904160 | Brooke Intl. | CYTOSMEAR BRUSH | 1990-11-02 | 52 |
Recalls for HHI devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2019-09-12.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code HHI?
HHI is the FDA product code for system, abortion, vacuum. It is a Class II device, regulated under 21 CFR 884.5070 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHI?
Class II, regulation 21 CFR 884.5070. Typical premarket route: 510(k).
How long does a 510(k) take for product code HHI?
Across 24 cleared submissions the average was 73 days from receipt to decision (median 56).
Which companies have the most HHI clearances?
Intl. Medical Technologies, Inc. (4); Cosmedtech, Inc. (3); Williams Specialty Products, Inc. (2); Gyrus Acmi (1); Acmi Corporation (1).
Have HHI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2019-09-12.
Next steps
- Run an FDA pathway report with predicate devices for product code HHI
- Run a recall and safety report across every HHI manufacturer
- Watch product code HHI 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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