FDA product code HED: Douche Apparatus, Vaginal, Therapeutic
HED is the FDA product code for douche apparatus, vaginal, therapeutic. It is a Class I device, regulated under 21 CFR 884.5900 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 12 510(k) submissions under HED, from 10 different applicants. The average 510(k) review took 100 days (median 94).
Classification
| Field | Value |
|---|---|
| Device name | Douche Apparatus, Vaginal, Therapeutic |
| Device class | Class I |
| Regulation | 21 CFR 884.5900 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HED clearance
Top HED applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Healthcare Group Laboratories, Inc. | 3 | 1980-10-03 |
| Abbott Research Group, Inc. | 1 | 2008-07-10 |
| Corisen Group, Ltd. | 1 | 2003-04-22 |
| Goomi Ehwa, Inc. | 1 | 2000-08-08 |
| Orion Life Systems, Inc. | 1 | 1990-08-06 |
5 more applicants have HED clearances. See the full list in Caduvo.
Most recent HED clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080200 | Abbott Research Group, Inc. | WATER WORKS DOUCHING DEVICE | 2008-07-10 | 167 |
| K030056 | Corisen Group, Ltd. | WORRY-REMOVER IRRIGATOR | 2003-04-22 | 106 |
| K000736 | Goomi Ehwa, Inc. | LA JOIE | 2000-08-08 | 154 |
| K902830 | Orion Life Systems, Inc. | PERI-BOTTLE | 1990-08-06 | 39 |
| K881216 | Geneva Laboratories, Inc. | GENT-L-KARE VAGINAL IRRIGATION SET | 1988-06-07 | 77 |
Recalls for HED devices
openFDA lists no recalls for product code HED.
Frequently asked questions
What is FDA product code HED?
HED is the FDA product code for douche apparatus, vaginal, therapeutic. It is a Class I device, regulated under 21 CFR 884.5900 and reviewed by the Obstetrics and Gynecology panel.
What device class is HED?
Class I, regulation 21 CFR 884.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HED?
Across 12 cleared submissions the average was 100 days from receipt to decision (median 94).
Which companies have the most HED clearances?
The Healthcare Group Laboratories, Inc. (3); Abbott Research Group, Inc. (1); Corisen Group, Ltd. (1); Goomi Ehwa, Inc. (1); Orion Life Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HED
- Run a recall and safety report across every HED manufacturer
- Watch product code HED 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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