FDA product code HFO: Recorder, Pressure, Intrauterine
HFO is the FDA product code for recorder, 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 4 510(k) submissions under HFO, from 4 different applicants. The average 510(k) review took 33 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Recorder, 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 |
Compare with all 510(k) review times · Search every HFO clearance
Top HFO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alexander Mfg. Co. | 1 | 1997-11-12 |
| Gabris Surgical Corp. | 1 | 1994-09-12 |
| Life Support, Inc. | 1 | 1979-09-17 |
| Sonicaid, Inc. | 1 | 1978-05-09 |
Most recent HFO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973850 | Alexander Mfg. Co. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 | 1997-11-12 | 35 |
| K943989 | Gabris Surgical Corp. | LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT | 1994-09-12 | 27 |
| K791633 | Life Support, Inc. | UC-2000 UTERINE CATHERIZATION SYSTEM | 1979-09-17 | 27 |
| K780487 | Sonicaid, Inc. | FETAL MONITORING SYSTEM | 1978-05-09 | 43 |
Recalls for HFO devices
openFDA lists no recalls for product code HFO.
Frequently asked questions
What is FDA product code HFO?
HFO is the FDA product code for recorder, 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 HFO?
Class II, regulation 21 CFR 884.2700. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFO?
Across 4 cleared submissions the average was 33 days from receipt to decision (median 31).
Which companies have the most HFO clearances?
Alexander Mfg. Co. (1); Gabris Surgical Corp. (1); Life Support, Inc. (1); Sonicaid, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HFO
- Run a recall and safety report across every HFO manufacturer
- Watch product code HFO 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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