FDA product code HGN: Stethoscope, Fetal
HGN is the FDA product code for stethoscope, fetal. It is a Class I device, regulated under 21 CFR 884.2900 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under HGN, from 2 different applicants. The average 510(k) review took 16 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Stethoscope, Fetal |
| Device class | Class I |
| Regulation | 21 CFR 884.2900 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HGN clearance
Top HGN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conphar, Inc. | 1 | 1981-12-08 |
| J. Sklar Mfg. Co., Inc. | 1 | 1977-01-12 |
Most recent HGN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K813298 | Conphar, Inc. | CONPHAR DELEE HILLIS STETHOSCOPE | 1981-12-08 | 15 |
| K761338 | J. Sklar Mfg. Co., Inc. | LEFF STETHOSCOPE FOR FETAL HEART | 1977-01-12 | 16 |
Recalls for HGN devices
openFDA lists no recalls for product code HGN.
Frequently asked questions
What is FDA product code HGN?
HGN is the FDA product code for stethoscope, fetal. It is a Class I device, regulated under 21 CFR 884.2900 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGN?
Class I, regulation 21 CFR 884.2900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HGN?
Across 2 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most HGN clearances?
Conphar, Inc. (1); J. Sklar Mfg. Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HGN
- Run a recall and safety report across every HGN manufacturer
- Watch product code HGN 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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