FDA product code HHW: Pessary, Vaginal
HHW is the FDA product code for pessary, vaginal. It is a Class II device, regulated under 21 CFR 884.3575 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 41 510(k) submissions under HHW, 7 in the last five years, from 27 different applicants. The average 510(k) review took 205 days (median 152); 119 days on average over the last three years. FDA has posted 17 recalls for HHW devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pessary, Vaginal |
| Device class | Class II |
| Regulation | 21 CFR 884.3575 |
| 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 HHW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 371 |
| 2019 | 2 | 96 |
| 2024 | 5 | 243 |
| 2025 | 1 | 56 |
| 2026 | 1 | 57 |
Compare with all 510(k) review times · Search every HHW clearance
Top HHW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Deschutes Medical Products, Inc. | 5 | 2000-09-18 |
| Panpac Medical Corporation | 4 | 2018-10-31 |
| Bioteque America, Inc. | 3 | 2001-12-27 |
| Johnson & Johnson Medical, Inc. | 3 | 1997-03-10 |
| Contipi , Ltd. | 2 | 2013-08-27 |
22 more applicants have HHW clearances. See the full list in Caduvo.
Most recent HHW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253698 | Cooper Surgical | Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes | 2026-01-20 | 57 |
| K250438 | CooperSurgical, Inc. | CooperSurgical Milex® Pessaries | 2025-04-11 | 56 |
| K240798 | Cntrl+, Inc. | Cntrl+ Bladder Support Pessary | 2024-12-17 | 270 |
| K232677 | Reia, LLC | Reia pessary | 2024-05-21 | 263 |
| K232525 | Watkins-Conti Products, Inc. | Yoni.Fit Bladder Support | 2024-05-17 | 270 |
Recalls for HHW devices
17 product recalls in 8 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code HHW?
HHW is the FDA product code for pessary, vaginal. It is a Class II device, regulated under 21 CFR 884.3575 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHW?
Class II, regulation 21 CFR 884.3575. Typical premarket route: 510(k).
How long does a 510(k) take for product code HHW?
Across 41 cleared submissions the average was 205 days from receipt to decision (median 152).
Which companies have the most HHW clearances?
Deschutes Medical Products, Inc. (5); Panpac Medical Corporation (4); Bioteque America, Inc. (3); Johnson & Johnson Medical, Inc. (3); Contipi , Ltd. (2).
Have HHW devices been recalled?
Yes: 17 product recalls across 8 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code HHW
- Run a recall and safety report across every HHW manufacturer
- Watch product code HHW 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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