510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921730Substantially Equivalent

C-Section Pack

Medikmark, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921730 is the FDA 510(k) clearance record for C-SECTION PACK, a class I device, cleared for Medikmark, Inc. on under FDA product code KOH (Instrument, Manual, General Obstetric-Gynecologic). FDA records list 8 510(k) clearances for Medikmark, Inc., from to . As of , FDA records show no recalls naming K921730.

Clearance record

Decision date
Received
(796 days to decision)
Product code
KOH Instrument, Manual, General Obstetric-Gynecologic
Regulation
21 CFR 884.4520
Device class
Class I
Review panel
Obstetrics/Gynecology
Applicant
Medikmark, Inc. 333 W. Wacker Dr., Chicago IL
510(k) summary
Statement
Third party review
No

Clearances, product code KOH

Trailing 12 months

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

FDA records show no clearances under product code KOH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KOH, 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