510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863471Substantially Equivalent

Colorado Medical Model Ptc 1000

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

K863471 is the FDA 510(k) clearance record for COLORADO MEDICAL MODEL PTC 1000, a class II device, cleared for Colorado Medical, Inc. on under FDA product code KXM (System Accessories, Extracorporeal). FDA records list 6 510(k) clearances for Colorado Medical, Inc., from to . As of , FDA records show no recalls naming K863471.

Clearance record

Decision date
Received
(23 days to decision)
Product code
KXM System Accessories, Extracorporeal
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Colorado Medical, Inc. Bergen Park Business Plz., Evergreen CO
Third party review
No

Clearances, product code KXM

Trailing 12 months

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

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