Cleared Traditional

K010131 - PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101

K010131 is an FDA 510(k) clearance for PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, manufactured by Aksys, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 434-day FDA review.

K010131 · Aksys, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
434d
Days
Class 2
Risk

K010131 is an FDA 510(k) clearance for the PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605.... Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Aksys, Ltd. (Lincolnshire, US). The FDA issued a Cleared decision on March 26, 2002 after a review of 434 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Aksys, Ltd. devices

FDA 510(k) Submission Details - K010131

510(k) Number K010131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date March 26, 2002
Days to Decision 434 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
304d slower than avg
Panel avg: 130d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K010131.
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LIFEMATE MLA MULTI-LINE ADAPTOR
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K013550 · Terumo Medical Corp. · Nov 2001
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
K012510 · Nxstage Medical, Inc. · Oct 2001