510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K143447Substantially Equivalent

Dilapan-S

Medicem Technology s.r.o, Kamenne Zehrovice, CZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143447 is the FDA 510(k) clearance record for Dilapan-S, a class II device, cleared for Medicem Technology S.R.O on under FDA product code PKN (Dilator, Cervical, Synthetic, Osmotic). FDA's definition for product code PKN reads: "Cervical softening and dilation". FDA records list one 510(k) clearance for Medicem Technology S.R.O. As of , FDA records show no recalls naming K143447.

Clearance record

Decision date
Received
(136 days to decision)
Product code
PKN Dilator, Cervical, Synthetic, Osmotic
Regulation
21 CFR 884.4260
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medicem Technology S.R.O Karlovarska Trida 20, Kamenne Zehrovice, CZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PKN

Trailing 12 months

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

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