FDA product code HFM: Monitor, Uterine Contraction, External (For Use In Clinic)
HFM is the FDA product code for monitor, uterine contraction, external (for use in clinic). It is a Class II device, regulated under 21 CFR 884.2720 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 23 510(k) submissions under HFM, from 19 different applicants. The average 510(k) review took 155 days (median 126). 1 PMA application cites this product code. FDA has posted 8 recalls for HFM devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Uterine Contraction, External (For Use In Clinic) |
| Device class | Class II |
| Regulation | 21 CFR 884.2720 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HFM clearance
Top HFM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventrex, Inc. | 2 | 2006-07-12 |
| Corometrics Medical Systems, Inc. | 2 | 1990-11-07 |
| Tokos Medical Corp. | 2 | 1989-11-03 |
| Aequitron Medical, Inc. | 2 | 1989-03-01 |
| Clinical Innovations, LLC | 1 | 2014-05-29 |
14 more applicants have HFM clearances. See the full list in Caduvo.
Most recent HFM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140163 | Clinical Innovations, LLC | KOALA TOCO | 2014-05-29 | 127 |
| K061044 | Ventrex, Inc. | FEATHERLITE AQUA TOCODYNAMOMETER | 2006-07-12 | 89 |
| K040392 | American I.V. Products, Inc. | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | 2004-09-14 | 210 |
| K013477 | Ventrex, Inc. | TOCO LITE, MODEL TD-01 | 2002-01-17 | 90 |
| K994353 | Precision Dynamics Corp. | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 | 2000-03-22 | 90 |
Recalls for HFM devices
8 product recalls in 2 recall events; 0 initiated in the last five years and 8 still open. Most recent: 2019-09-19.
| Year | Recalls |
|---|---|
| 2019 | 8 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8608 — Miscellaneous external component, supply or accessory for use with the argus ii retinal prosthesis system
Frequently asked questions
What is FDA product code HFM?
HFM is the FDA product code for monitor, uterine contraction, external (for use in clinic). It is a Class II device, regulated under 21 CFR 884.2720 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFM?
Class II, regulation 21 CFR 884.2720. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFM?
Across 23 cleared submissions the average was 155 days from receipt to decision (median 126).
Which companies have the most HFM clearances?
Ventrex, Inc. (2); Corometrics Medical Systems, Inc. (2); Tokos Medical Corp. (2); Aequitron Medical, Inc. (2); Clinical Innovations, LLC (1).
Have HFM devices been recalled?
Yes: 8 product recalls across 2 recall events; the most recent began 2019-09-19.
Next steps
- Run an FDA pathway report with predicate devices for product code HFM
- Run a recall and safety report across every HFM manufacturer
- Watch product code HFM 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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