510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013575Substantially Equivalent

Kps-I, the Kidney Perfusion Solution

Organ Recovery Systems, Inc., Charleston SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013575 is the FDA 510(k) clearance record for KPS-I, THE KIDNEY PERFUSION SOLUTION, a class II device, cleared for Organ Recovery Systems, Inc. on under FDA product code KDN (System, Perfusion, Kidney). FDA records list 4 510(k) clearances for Organ Recovery Systems, Inc., from to . As of , FDA records show no recalls naming K013575.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KDN System, Perfusion, Kidney
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Organ Recovery Systems, Inc. 701 E. Bay St., Charleston SC
510(k) summary
Summary
Third party review
No

Clearances, product code KDN

Trailing 12 months
3 clearances under product code KDN in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KDN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260