FDA product code HGW: Sampler, Blood, Fetal
HGW is the FDA product code for sampler, blood, fetal. It is a Class II device, regulated under 21 CFR 884.1560 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under HGW, from 2 different applicants. The average 510(k) review took 36 days (median 34).
Classification
| Field | Value |
|---|---|
| Device name | Sampler, Blood, Fetal |
| Device class | Class II |
| Regulation | 21 CFR 884.1560 |
| 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 HGW clearance
Top HGW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Transidyne General Corp. | 3 | 1989-03-28 |
| A & A Medical, Inc. | 1 | 1989-01-12 |
Most recent HGW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891388 | Transidyne General Corp. | 1570 - FETAL BLOOD SAMPLING KIT | 1989-03-28 | 14 |
| K884685 | A & A Medical, Inc. | ROCKET FETAL BLOOD SAMPLING TRAY | 1989-01-12 | 65 |
| K831459 | Transidyne General Corp. | FETAL BLOOD SAMPLING KIT #1560 | 1983-06-30 | 55 |
| K810028 | Transidyne General Corp. | FETAL BLOOD SAMPLING KIT MODEL 1560 | 1981-01-16 | 10 |
Recalls for HGW devices
openFDA lists no recalls for product code HGW.
Frequently asked questions
What is FDA product code HGW?
HGW is the FDA product code for sampler, blood, fetal. It is a Class II device, regulated under 21 CFR 884.1560 and reviewed by the Obstetrics and Gynecology panel.
What device class is HGW?
Class II, regulation 21 CFR 884.1560. Typical premarket route: 510(k).
How long does a 510(k) take for product code HGW?
Across 4 cleared submissions the average was 36 days from receipt to decision (median 34).
Which companies have the most HGW clearances?
Transidyne General Corp. (3); A & A Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HGW
- Run a recall and safety report across every HGW manufacturer
- Watch product code HGW 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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