FDA product code HEI: Monitor, Heart-Valve Movement, Fetal, Ultrasonic
HEI is the FDA product code for monitor, heart-valve movement, 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 3 510(k) submissions under HEI, from 3 different applicants. The average 510(k) review took 167 days (median 172).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Heart-Valve Movement, 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 HEI clearance
Top HEI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Doctor'S Research Group, Inc. | 1 | 2002-02-12 |
| Snowden-Pencer | 1 | 1992-06-09 |
| M.D. Engineering, Inc. | 1 | 1991-08-26 |
Most recent HEI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012003 | Doctor'S Research Group, Inc. | DRG REACTION CHAMBER/SAFETY TIP | 2002-02-12 | 230 |
| K920985 | Snowden-Pencer | SNOWDEN-PENCER IRRIGATION PUMP | 1992-06-09 | 99 |
| K910982 | M.D. Engineering, Inc. | INNERVISION IRRIGATION PUMP | 1991-08-26 | 172 |
Recalls for HEI devices
openFDA lists no recalls for product code HEI.
Frequently asked questions
What is FDA product code HEI?
HEI is the FDA product code for monitor, heart-valve movement, 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 HEI?
Class II, regulation 21 CFR 884.2660. Typical premarket route: 510(k).
How long does a 510(k) take for product code HEI?
Across 3 cleared submissions the average was 167 days from receipt to decision (median 172).
Which companies have the most HEI clearances?
Doctor'S Research Group, Inc. (1); Snowden-Pencer (1); M.D. Engineering, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HEI
- Run a recall and safety report across every HEI manufacturer
- Watch product code HEI 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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