FDA product code HDD: Table, Obstetrical, Ac-Powered (And Accessories)
HDD is the FDA product code for table, obstetrical, ac-powered (and accessories). It is a Class II device, regulated under 21 CFR 884.4900 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 7 510(k) submissions under HDD, from 6 different applicants. The average 510(k) review took 121 days (median 116). FDA has posted 8 recalls for HDD devices.
Classification
| Field | Value |
|---|---|
| Device name | Table, Obstetrical, Ac-Powered (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.4900 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HDD clearance
Top HDD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Adel Medical , Ltd. | 2 | 1988-01-21 |
| Stryker Corp. | 1 | 1995-10-16 |
| Hill-Rom, Inc. | 1 | 1992-04-20 |
| Alton Dean Medical, Inc. | 1 | 1988-06-21 |
| Affiliated Hospital Products, Inc. | 1 | 1977-10-27 |
1 more applicants have HDD clearances. See the full list in Caduvo.
Most recent HDD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950889 | Stryker Corp. | ADEL 5000 | 1995-10-16 | 230 |
| K914309 | Hill-Rom, Inc. | THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES | 1992-04-20 | 208 |
| K875123 | Alton Dean Medical, Inc. | ORCEPAD | 1988-06-21 | 189 |
| K874610 | Adel Medical , Ltd. | ADEL MODEL 2100 BIRTHING BED | 1988-01-21 | 73 |
| K810886 | Adel Medical , Ltd. | ADEL MEDICAL BIRTHING BED, #LD-500 | 1981-04-23 | 22 |
Recalls for HDD devices
8 product recalls in 6 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-03-06.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code HDD?
HDD is the FDA product code for table, obstetrical, ac-powered (and accessories). It is a Class II device, regulated under 21 CFR 884.4900 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDD?
Class II, regulation 21 CFR 884.4900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HDD?
Across 7 cleared submissions the average was 121 days from receipt to decision (median 116).
Which companies have the most HDD clearances?
Adel Medical , Ltd. (2); Stryker Corp. (1); Hill-Rom, Inc. (1); Alton Dean Medical, Inc. (1); Affiliated Hospital Products, Inc. (1).
Have HDD devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2020-03-06.
Next steps
- Run an FDA pathway report with predicate devices for product code HDD
- Run a recall and safety report across every HDD manufacturer
- Watch product code HDD 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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