FDA product code HEK: Monitor, Heart Sound, Fetal, Ultrasonic
HEK is the FDA product code for monitor, heart sound, 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 5 510(k) submissions under HEK, from 5 different applicants. The average 510(k) review took 105 days (median 128).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Heart Sound, 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 HEK clearance
Top HEK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Icare Newlife Technologies, Inc. | 1 | 2015-03-20 |
| Summit Doppler Systems, Inc. | 1 | 2006-04-10 |
| Advanced Medical Systems, Inc. | 1 | 1990-10-22 |
| Diagnosis Related Systems, Inc. | 1 | 1988-12-15 |
| Terumo America, Inc. | 1 | 1977-07-14 |
Most recent HEK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142769 | Icare Newlife Technologies, Inc. | Fetal Doppler | 2015-03-20 | 176 |
| K060410 | Summit Doppler Systems, Inc. | ECHOHEART TRANSVAGINAL DOPPLER PROBE | 2006-04-10 | 53 |
| K902190 | Advanced Medical Systems, Inc. | FETAL PULSE DETECTOR MODEL DOP-1 | 1990-10-22 | 159 |
| K883334 | Diagnosis Related Systems, Inc. | BIODOP(TM) | 1988-12-15 | 128 |
| K771211 | Terumo America, Inc. | DOPPLER (UTD-5 & UTD-6) | 1977-07-14 | 9 |
Recalls for HEK devices
openFDA lists no recalls for product code HEK.
Frequently asked questions
What is FDA product code HEK?
HEK is the FDA product code for monitor, heart sound, 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 HEK?
Class II, regulation 21 CFR 884.2660. Typical premarket route: 510(k).
How long does a 510(k) take for product code HEK?
Across 5 cleared submissions the average was 105 days from receipt to decision (median 128).
Which companies have the most HEK clearances?
Icare Newlife Technologies, Inc. (1); Summit Doppler Systems, Inc. (1); Advanced Medical Systems, Inc. (1); Diagnosis Related Systems, Inc. (1); Terumo America, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HEK
- Run a recall and safety report across every HEK manufacturer
- Watch product code HEK 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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