510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894264Substantially Equivalent

Kdf-2.3

Unimar, Inc., Wilton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894264 is the FDA 510(k) clearance record for KDF-2.3, a class II device, cleared for Unimar, Inc. on under FDA product code HDR (Cap, Cervical). FDA records list 10 510(k) clearances for Unimar, Inc., from to . As of , FDA records show no recalls naming K894264.

Clearance record

Decision date
Received
(56 days to decision)
Product code
HDR Cap, Cervical
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Unimar, Inc. 475 Danbury Rd., Wilton CT
Third party review
No

Clearances, product code HDR

Trailing 12 months

FDA records hold no clearances under product code HDR in the trailing twelve months.

FDA records show no clearances under product code HDR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HDR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260