FDA product code HIS: Condom
HIS is the FDA product code for condom. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 401 510(k) submissions under HIS, 18 in the last five years, from 177 different applicants. The average 510(k) review took 163 days (median 115); 188 days on average over the last three years. FDA has posted 7 recalls for HIS devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Condom |
| Device class | Class II |
| Regulation | 21 CFR 884.5300 |
| 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 HIS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 102 |
| 2018 | 2 | 160 |
| 2019 | 1 | 278 |
| 2020 | 4 | 222 |
| 2021 | 5 | 186 |
| 2022 | 10 | 174 |
| 2023 | 2 | 155 |
| 2025 | 5 | 117 |
| 2026 | 1 | 258 |
Compare with all 510(k) review times · Search every HIS clearance
Top HIS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carter Products | 15 | 1992-02-03 |
| Okamoto USA, Inc. | 14 | 2026-05-04 |
| Mayer Laboratories | 13 | 1995-11-08 |
| Church & Dwight Co., Inc. | 12 | 2025-02-21 |
| Ansell, Inc. | 12 | 1999-07-21 |
172 more applicants have HIS clearances. See the full list in Caduvo.
Most recent HIS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252622 | Okamoto USA, Inc. | Male Latex Condom HA | 2026-05-04 | 258 |
| K252521 | Suretex Limited | LifeStyles® HydraFeel Natural Rubber Latex Condom | 2025-11-18 | 99 |
| K250034 | Shaoguan Regenex Pharmaceuticals Co., Ltd. | Natural rubber latex male condom | 2025-07-11 | 185 |
| K243421 | Lelo, Inc. | Lelo Hex Lubricated Natural Rubber Latex Condom | 2025-03-07 | 123 |
| K243640 | Church & Dwight Co., Inc. | Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy) | 2025-02-21 | 88 |
Recalls for HIS devices
7 product recalls in 7 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-12-26.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code HIS?
HIS is the FDA product code for condom. It is a Class II device, regulated under 21 CFR 884.5300 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIS?
Class II, regulation 21 CFR 884.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code HIS?
Across 401 cleared submissions the average was 163 days from receipt to decision (median 115).
Which companies have the most HIS clearances?
Carter Products (15); Okamoto USA, Inc. (14); Mayer Laboratories (13); Church & Dwight Co., Inc. (12); Ansell, Inc. (12).
Have HIS devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2025-12-26.
Next steps
- Run an FDA pathway report with predicate devices for product code HIS
- Run a recall and safety report across every HIS manufacturer
- Watch product code HIS 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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