510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863785Substantially Equivalent

Makler Catheter

I M, Inc., Fairfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863785 is the FDA 510(k) clearance record for MAKLER CATHETER, a class II device, cleared for I M, Inc. on under FDA product code HDR (Cap, Cervical). FDA records list 15 510(k) clearances for I M, Inc., from to . As of , FDA records show no recalls naming K863785.

Clearance record

Decision date
Received
(76 days to decision)
Product code
HDR Cap, Cervical
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
I M, Inc. P.O. Box 658, Fairfield NJ
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