FDA product code HDF: Speculum, Vaginal, Metal
HDF is the FDA product code for speculum, vaginal, metal. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 11 510(k) submissions under HDF, from 8 different applicants. The average 510(k) review took 77 days (median 27). FDA has posted 3 recalls for HDF devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Speculum, Vaginal, Metal |
| Device class | Class I |
| Regulation | 21 CFR 884.4520 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HDF clearance
Top HDF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zinnanti Surgical Instruments, Inc. | 2 | 1989-03-22 |
| Downs Surgical , Ltd. | 2 | 1985-10-29 |
| Conphar, Inc. | 2 | 1982-05-24 |
| Thomasville Medical Assoc. | 1 | 1994-02-28 |
| Gynescope Corp. | 1 | 1990-06-07 |
3 more applicants have HDF clearances. See the full list in Caduvo.
Most recent HDF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K926429 | Thomasville Medical Assoc. | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | 1994-02-28 | 432 |
| K902019 | Gynescope Corp. | MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS | 1990-06-07 | 35 |
| K891041 | Zinnanti Surgical Instruments, Inc. | MIYA SPECULUM | 1989-03-22 | 22 |
| K891044 | Zinnanti Surgical Instruments, Inc. | LASER SPECULA | 1989-03-17 | 17 |
| K890375 | Kinetic Medical Products | VAGINAL SPECULUM | 1989-02-13 | 21 |
Recalls for HDF devices
3 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HDF?
HDF is the FDA product code for speculum, vaginal, metal. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDF?
Class I, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HDF?
Across 11 cleared submissions the average was 77 days from receipt to decision (median 27).
Which companies have the most HDF clearances?
Zinnanti Surgical Instruments, Inc. (2); Downs Surgical , Ltd. (2); Conphar, Inc. (2); Thomasville Medical Assoc. (1); Gynescope Corp. (1).
Have HDF devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HDF
- Run a recall and safety report across every HDF manufacturer
- Watch product code HDF 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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