FDA product code HEL: Monitor, Heart Rate, Fetal, Ultrasonic
HEL is the FDA product code for monitor, heart rate, fetal, ultrasonic. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 7 510(k) submissions under HEL, from 6 different applicants. The average 510(k) review took 282 days (median 134).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Heart Rate, Fetal, Ultrasonic |
| Device class | Class II |
| Regulation | 21 CFR 884.2660 |
| 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 HEL clearance
Top HEL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oxford Instruments, Plc. | 2 | 1995-08-24 |
| Card Guard Scientific Survival , Ltd. | 1 | 2001-07-09 |
| Medical Cables, Inc. | 1 | 2001-06-22 |
| Corometrics Medical Systems, Inc. | 1 | 1998-12-11 |
| Alexander Mfg. Co. | 1 | 1997-06-06 |
1 more applicants have HEL clearances. See the full list in Caduvo.
Most recent HEL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003876 | Card Guard Scientific Survival , Ltd. | US SENSOR #CG-930P; TOCO SENSOR CG-940P | 2001-07-09 | 206 |
| K010920 | Medical Cables, Inc. | TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING | 2001-06-22 | 87 |
| K982651 | Corometrics Medical Systems, Inc. | COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER | 1998-12-11 | 134 |
| K971240 | Alexander Mfg. Co. | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 | 1997-06-06 | 65 |
| K930714 | Oxford Instruments, Plc. | SONICAID MODEL TEAM FECG IUP | 1995-08-24 | 924 |
Recalls for HEL devices
openFDA lists no recalls for product code HEL.
Frequently asked questions
What is FDA product code HEL?
HEL is the FDA product code for monitor, heart rate, fetal, ultrasonic. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Obstetrics and Gynecology panel.
What device class is HEL?
Class II, regulation 21 CFR 884.2660. Typical premarket route: 510(k).
How long does a 510(k) take for product code HEL?
Across 7 cleared submissions the average was 282 days from receipt to decision (median 134).
Which companies have the most HEL clearances?
Oxford Instruments, Plc. (2); Card Guard Scientific Survival , Ltd. (1); Medical Cables, Inc. (1); Corometrics Medical Systems, Inc. (1); Alexander Mfg. Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HEL
- Run a recall and safety report across every HEL manufacturer
- Watch product code HEL 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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