510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893531Substantially Equivalent

Cuff Speculum

Mountain Medical Equipment, Inc., Littleton CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893531 is the FDA 510(k) clearance record for CUFF SPECULUM, a class II device, cleared for Mountain Medical Equipment, Inc. on under FDA product code KPL (Colonic Irrigation System). FDA records list 20 510(k) clearances for Mountain Medical Equipment, Inc., from to . As of , FDA records show no recalls naming K893531.

Clearance record

Decision date
Received
(45 days to decision)
Product code
KPL Colonic Irrigation System
Regulation
21 CFR 876.5220
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mountain Medical Equipment, Inc. 10488 W. Centennial Rd., Littleton CO
Third party review
No

Clearances, product code KPL

Trailing 12 months

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

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