FDA product code HDQ: Dilator, Cervical, Fixed Size
HDQ is the FDA product code for dilator, cervical, fixed size. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 6 510(k) submissions under HDQ, from 6 different applicants. The average 510(k) review took 138 days (median 42). FDA has posted 4 recalls for HDQ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Cervical, Fixed Size |
| Device class | Class I |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HDQ clearance
Top HDQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Thomasville Medical Assoc. | 1 | 1994-02-24 |
| Cook Ob/Gyn | 1 | 1990-09-13 |
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-03-17 |
| Kinetic Medical Products | 1 | 1989-02-13 |
| Gynemetrics, Inc. | 1 | 1981-07-16 |
1 more applicants have HDQ clearances. See the full list in Caduvo.
Most recent HDQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930034 | Thomasville Medical Assoc. | CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON | 1994-02-24 | 415 |
| K896701 | Cook Ob/Gyn | TEFLON CERVICAL ACCESS SET | 1990-09-13 | 289 |
| K891029 | Zinnanti Surgical Instruments, Inc. | CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL | 1989-03-17 | 17 |
| K890377 | Kinetic Medical Products | FIXED-SIZE UTERINE DILATOR | 1989-02-13 | 21 |
| K811568 | Gynemetrics, Inc. | CERVICAL DILATOR | 1981-07-16 | 42 |
Recalls for HDQ devices
4 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code HDQ?
HDQ is the FDA product code for dilator, cervical, fixed size. It is a Class I device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDQ?
Class I, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HDQ?
Across 6 cleared submissions the average was 138 days from receipt to decision (median 42).
Which companies have the most HDQ clearances?
Thomasville Medical Assoc. (1); Cook Ob/Gyn (1); Zinnanti Surgical Instruments, Inc. (1); Kinetic Medical Products (1); Gynemetrics, Inc. (1).
Have HDQ devices been recalled?
Yes: 4 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 HDQ
- Run a recall and safety report across every HDQ manufacturer
- Watch product code HDQ 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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