510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901426Substantially Equivalent

Colonic Balloon Dilator

TeleMed Systems, Hudson MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901426 is the FDA 510(k) clearance record for COLONIC BALLOON DILATOR, a class I device, cleared for Telemed Systems, Inc. on under FDA product code FFP (Dilator, Rectal). FDA records list 22 510(k) clearances for Telemed Systems, Inc., from to . As of , FDA records show no recalls naming K901426.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FFP Dilator, Rectal
Regulation
21 CFR 876.5450
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Telemed Systems, Inc. 8 Kane Industrial Dr., Hudson MA
Third party review
No

Clearances, product code FFP

Trailing 12 months

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

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