Cleared Traditional

K990229 - HPA PORTABLE KIDNEY PRESERVATION SYSTEM

K990229 is an FDA 510(k) clearance for HPA PORTABLE KIDNEY PRESERVATION SYSTEM, manufactured by Justec Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDN cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K990229 · Justec Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
283d
Days
Class 2
Risk

K990229 is an FDA 510(k) clearance for the HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1. Classified as System, Perfusion, Kidney (product code KDN), Class II - Special Controls.

Submitted by Justec Medical Products, Inc. (Holbrook, US). The FDA issued a Cleared decision on November 4, 1999 after a review of 283 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5880 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Justec Medical Products, Inc. devices

FDA 510(k) Submission Details - K990229

510(k) Number K990229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1999
Decision Date November 04, 1999
Days to Decision 283 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 130d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDN Device Classification - Class 2, Special Controls

Product Code KDN System, Perfusion, Kidney
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.