510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K990229Substantially Equivalent

Hpa Portable Kidney Preservation System, Model J-1000-1

Justec Medical Products, Inc., Holbrook NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990229 is the FDA 510(k) clearance record for HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1, a class II device, cleared for Justec Medical Products, Inc. on under FDA product code KDN (System, Perfusion, Kidney). FDA records list one 510(k) clearance for Justec Medical Products, Inc. As of , FDA records show no recalls naming K990229.

Clearance record

Decision date
Received
(283 days to decision)
Product code
KDN System, Perfusion, Kidney
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Justec Medical Products, Inc. 1724 Church St., Holbrook NY
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