FDA product code MLT: Pelvic Exam Kit
MLT is the FDA product code for pelvic exam kit. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under MLT. The average 510(k) review took 333 days (median 333). FDA has posted 10 recalls for MLT devices, 7 initiated in the last five years.
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Classification
| Field | Value |
|---|---|
| Device name | Pelvic Exam Kit |
| Device class | Class II |
| 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 MLT clearance
Top MLT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carapace, Inc. | 1 | 1994-03-07 |
Most recent MLT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931822 | Carapace, Inc. | CARAPACE PELVIC EXAM TRAYS | 1994-03-07 | 333 |
Recalls for MLT devices
10 product recalls in 8 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2026-05-04.
| Year | Recalls |
|---|---|
| 2019 | 3 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code MLT?
MLT is the FDA product code for pelvic exam kit. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is MLT?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MLT?
Across 1 cleared submissions the average was 333 days from receipt to decision (median 333).
Which companies have the most MLT clearances?
Carapace, Inc. (1).
Have MLT devices been recalled?
Yes: 10 product recalls across 8 recall events; the most recent began 2026-05-04.
Next steps
- Run an FDA pathway report with predicate devices for product code MLT
- Run a recall and safety report across every MLT manufacturer
- Watch product code MLT 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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