MLTClass II

Pelvic Exam Kit

21 CFR 884.4530 / Obstetrics/Gynecology

MLT is the FDA product code for Pelvic Exam Kit, a class II device type, regulated under 21 CFR 884.4530. FDA's definition for this code reads: "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))...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1994-03-07, and 10 recalls.

Classification record

Product code: MLT
Device name: Pelvic Exam Kit
FDA 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.
Regulation: 21 CFR 884.4530
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 10

Clearances, product code MLT

By decision year

1 clearance under product code MLT with a decision year between 1994 and 1994, 1994 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code MLT by decision year
Year	Clearances
1994	1

Applicants with the most clearances

Product code MLT

Applicants holding the most 510(k) clearances under product code MLT
Applicant	Clearances
Carapace, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order