510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841153Substantially Equivalent

Adaptor Hr-3000 Reuse

Colorado Medical, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841153 is the FDA 510(k) clearance record for ADAPTOR HR-3000 REUSE, a class II device, cleared for Colorado Medical, Inc. on under FDA product code LIF (Dialyzer Reprocessing System). FDA records list 6 510(k) clearances for Colorado Medical, Inc., from to . As of , FDA records show no recalls naming K841153.

Clearance record

Decision date
Received
(119 days to decision)
Product code
LIF Dialyzer Reprocessing System
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Colorado Medical, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LIF

Trailing 12 months

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

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