510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812615Substantially Equivalent

Tm-Capd

Tri-Med, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812615 is the FDA 510(k) clearance record for TM-CAPD, a class II device, cleared for Tri-Med, Inc. on under FDA product code KPP (Peritoneal Dialysate Filter). FDA records list 29 510(k) clearances for Tri-Med, Inc., from to . As of , FDA records show no recalls naming K812615.

Clearance record

Decision date
Received
(112 days to decision)
Product code
KPP Peritoneal Dialysate Filter
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Tri-Med, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KPP

Trailing 12 months

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

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