FDA product code HFN: Transducer, Pressure, Intrauterine
HFN is the FDA product code for transducer, pressure, intrauterine. It is a Class II device, regulated under 21 CFR 884.2700 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 9 510(k) submissions under HFN, 1 in the last five years, from 5 different applicants. The average 510(k) review took 151 days (median 89); 58 days on average over the last three years. FDA has posted 1 recall for HFN devices.
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Pressure, Intrauterine |
| Device class | Class II |
| Regulation | 21 CFR 884.2700 |
| 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 HFN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 58 |
Compare with all 510(k) review times · Search every HFN clearance
Top HFN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clinical Innovations, Inc. | 3 | 1998-02-19 |
| Utah Medical Products, Inc. | 2 | 1996-07-10 |
| Telos Medical Corp. | 2 | 1992-10-27 |
| Clinical Innovations, LLC | 1 | 2025-05-22 |
| Laurel Medical Corp. | 1 | 1989-06-12 |
Most recent HFN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250897 | Clinical Innovations, LLC | Koala Intrauterine Pressure Catheter (IPC-5000E) | 2025-05-22 | 58 |
| K974389 | Clinical Innovations, Inc. | KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER | 1998-02-19 | 90 |
| K973746 | Clinical Innovations, Inc. | PRE-FILLED SYRINGE FOR KOALA IUP | 1997-11-24 | 54 |
| K961424 | Utah Medical Products, Inc. | INTRAN 500 | 1996-07-10 | 89 |
| K954955 | Clinical Innovations, Inc. | STORC INTRAUTERINE PRESSURE CATHETER | 1996-04-17 | 173 |
Recalls for HFN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-06-16.
Frequently asked questions
What is FDA product code HFN?
HFN is the FDA product code for transducer, pressure, intrauterine. It is a Class II device, regulated under 21 CFR 884.2700 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFN?
Class II, regulation 21 CFR 884.2700. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFN?
Across 9 cleared submissions the average was 151 days from receipt to decision (median 89).
Which companies have the most HFN clearances?
Clinical Innovations, Inc. (3); Utah Medical Products, Inc. (2); Telos Medical Corp. (2); Clinical Innovations, LLC (1); Laurel Medical Corp. (1).
Have HFN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-06-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HFN
- Run a recall and safety report across every HFN manufacturer
- Watch product code HFN 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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