FDA product code HHP: Table, Obstetrical, Manual (And Accessories)
HHP is the FDA product code for table, obstetrical, manual (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 2 510(k) submissions under HHP, from 2 different applicants. The average 510(k) review took 124 days (median 124).
Classification
| Field | Value |
|---|---|
| Device name | Table, Obstetrical, Manual (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 HHP clearance
Top HHP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tenet Medical Engineering | 1 | 1997-02-14 |
| Yellow Springs Instrument Co., Inc. | 1 | 1982-12-13 |
Most recent HHP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963505 | Tenet Medical Engineering | TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM | 1997-02-14 | 164 |
| K822812 | Yellow Springs Instrument Co., Inc. | YSI MODEL 23L LACTATE ANALYZER | 1982-12-13 | 84 |
Recalls for HHP devices
openFDA lists no recalls for product code HHP.
Frequently asked questions
What is FDA product code HHP?
HHP is the FDA product code for table, obstetrical, manual (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 HHP?
Class II, regulation 21 CFR 884.4900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HHP?
Across 2 cleared submissions the average was 124 days from receipt to decision (median 124).
Which companies have the most HHP clearances?
Tenet Medical Engineering (1); Yellow Springs Instrument Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HHP
- Run a recall and safety report across every HHP manufacturer
- Watch product code HHP 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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