FDA product code HFX: Clamp, Circumcision
HFX is the FDA product code for clamp, circumcision. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 27 510(k) submissions under HFX, 3 in the last five years, from 25 different applicants. The average 510(k) review took 179 days (median 100); 268 days on average over the last three years. FDA has posted 14 recalls for HFX devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Circumcision |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| 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 HFX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 431 |
| 2023 | 1 | 268 |
| 2026 | 1 | 268 |
Compare with all 510(k) review times · Search every HFX clearance
Top HFX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thomasville Medical Assoc. | 2 | 1994-02-25 |
| Tri-State Hospital Supply Corp. | 2 | 1994-02-17 |
| Medline Industries, LP | 1 | 2026-02-25 |
| Wee Medical | 1 | 2023-02-02 |
| Medline Industries, Inc. | 1 | 2022-11-18 |
20 more applicants have HFX clearances. See the full list in Caduvo.
Most recent HFX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251687 | Medline Industries, LP | Konig Bell Circumcision Clamp | 2026-02-25 | 268 |
| K221356 | Wee Medical | Wee Bell | 2023-02-02 | 268 |
| K212911 | Medline Industries, Inc. | Konig Mogen Clamp | 2022-11-18 | 431 |
| K151095 | Novadien Healthcare | Circumplast Circumcision Device | 2015-09-18 | 148 |
| K142163 | Medicfit Technology Sdn Bhd | MALE CIRCUMCISION KITS:RAPIDECLAMP | 2015-04-20 | 257 |
Recalls for HFX devices
14 product recalls in 10 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-09-03.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2023 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HFX?
HFX is the FDA product code for clamp, circumcision. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFX?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFX?
Across 27 cleared submissions the average was 179 days from receipt to decision (median 100).
Which companies have the most HFX clearances?
Thomasville Medical Assoc. (2); Tri-State Hospital Supply Corp. (2); Medline Industries, LP (1); Wee Medical (1); Medline Industries, Inc. (1).
Have HFX devices been recalled?
Yes: 14 product recalls across 10 recall events; the most recent began 2024-09-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HFX
- Run a recall and safety report across every HFX manufacturer
- Watch product code HFX 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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