FDA product code HDA: Forceps, Obstetrical
HDA is the FDA product code for forceps, obstetrical. It is a Class II device, regulated under 21 CFR 884.4400 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 10 510(k) submissions under HDA, from 10 different applicants. The average 510(k) review took 135 days (median 86). FDA has posted 7 recalls for HDA devices.
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Obstetrical |
| Device class | Class II |
| Regulation | 21 CFR 884.4400 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HDA clearance
Top HDA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumed International, Inc. | 1 | 2010-04-29 |
| Dimeda Instrumente GmbH | 1 | 2010-01-08 |
| Tekno Medical Optik-Chirurgie GmbH & Co. | 1 | 2002-02-11 |
| Baxter Healthcare Corp | 1 | 1995-08-04 |
| Columbia Medical & Surgical, Inc. | 1 | 1993-09-07 |
5 more applicants have HDA clearances. See the full list in Caduvo.
Most recent HDA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100517 | Instrumed International, Inc. | INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX | 2010-04-29 | 65 |
| K092827 | Dimeda Instrumente GmbH | DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX | 2010-01-08 | 116 |
| K013747 | Tekno Medical Optik-Chirurgie GmbH & Co. | TEKNO-MEDICAL OBSTETRICAL FORCEPS | 2002-02-11 | 90 |
| K951529 | Baxter Healthcare Corp | V. MUELLER OBSTETRICAL (OB) FORCEPS | 1995-08-04 | 123 |
| K914552 | Columbia Medical & Surgical, Inc. | CMI VACUUM PUMP | 1993-09-07 | 697 |
Recalls for HDA devices
7 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-03-13.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2019 | 3 |
Frequently asked questions
What is FDA product code HDA?
HDA is the FDA product code for forceps, obstetrical. It is a Class II device, regulated under 21 CFR 884.4400 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDA?
Class II, regulation 21 CFR 884.4400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HDA?
Across 10 cleared submissions the average was 135 days from receipt to decision (median 86).
Which companies have the most HDA clearances?
Instrumed International, Inc. (1); Dimeda Instrumente GmbH (1); Tekno Medical Optik-Chirurgie GmbH & Co. (1); Baxter Healthcare Corp (1); Columbia Medical & Surgical, Inc. (1).
Have HDA devices been recalled?
Yes: 7 product recalls across 2 recall events; the most recent began 2019-03-13.
Next steps
- Run an FDA pathway report with predicate devices for product code HDA
- Run a recall and safety report across every HDA manufacturer
- Watch product code HDA 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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