FDA product code HIB: Speculum, Vaginal, Nonmetal
HIB is the FDA product code for speculum, vaginal, nonmetal. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 72 510(k) submissions under HIB, 1 in the last five years, from 62 different applicants. The average 510(k) review took 146 days (median 84); 234 days on average over the last three years. FDA has posted 6 recalls for HIB devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Speculum, Vaginal, Nonmetal |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for HIB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 234 |
Compare with all 510(k) review times · Search every HIB clearance
Top HIB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Welch Allyn, Inc. | 3 | 2012-03-23 |
| Sol Weiss MD, Inc. | 3 | 2002-06-19 |
| C.I.S.A. Import Export C/O Larson and Taylor | 3 | 1988-12-20 |
| Femspec LLC | 2 | 2006-02-02 |
| Zinnanti Surgical Instruments, Inc. | 2 | 1997-06-13 |
57 more applicants have HIB clearances. See the full list in Caduvo.
Most recent HIB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252208 | Ford Medtech, LLC | JFord Speculum Sleeve | 2026-03-06 | 234 |
| K133857 | Proa Medical, Inc. | BRELLA-SPEC(TM) VAGINAL SPECULUM | 2014-04-28 | 130 |
| K132668 | Iob Medical, Inc. | IOB DISPOSABLE SPECULUM | 2014-01-17 | 143 |
| K130046 | Clearspec, LLC | CLEARSPEC SINGLE USE VAGINAL SPECULUM | 2013-08-06 | 210 |
| K120743 | Welch Allyn, Inc. | SPECULUM, VAGINAL, NONMETAL | 2012-03-23 | 11 |
Recalls for HIB devices
6 product recalls in 4 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-07-13.
| Year | Recalls |
|---|---|
| 2025 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code HIB?
HIB is the FDA product code for speculum, vaginal, nonmetal. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIB?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HIB?
Across 72 cleared submissions the average was 146 days from receipt to decision (median 84).
Which companies have the most HIB clearances?
Welch Allyn, Inc. (3); Sol Weiss MD, Inc. (3); C.I.S.A. Import Export C/O Larson and Taylor (3); Femspec LLC (2); Zinnanti Surgical Instruments, Inc. (2).
Have HIB devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2026-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code HIB
- Run a recall and safety report across every HIB manufacturer
- Watch product code HIB 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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