Cleared Traditional

K001283 - LIFEMATE HEMOFILTRATION SYSTEM

K001283 is an FDA 510(k) clearance for LIFEMATE HEMOFILTRATION SYSTEM, manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K001283 · Nxstage Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 2001
Decision
271d
Days
Class 2
Risk

K001283 is an FDA 510(k) clearance for the LIFEMATE HEMOFILTRATION SYSTEM. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Tewksburt, US). The FDA issued a Cleared decision on January 17, 2001 after a review of 271 days - an extended review cycle.

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: 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 Nxstage Medical, Inc. devices

FDA 510(k) Submission Details - K001283

510(k) Number K001283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2000
Decision Date January 17, 2001
Days to Decision 271 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 130d · This submission: 271d
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 246
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K001283.
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
K010667 · Gambro Renal Products · Jun 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · Baxter Healthcare Corp · Feb 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · Terumo Medical Corp. · Feb 2001
FRESENIUS OPTIFLUX 200A
K003498 · Fresenius Medical Care North America · Jan 2001
FRESENIUS OPTIFLUX 200NR
K002277 · Fresenius Medical Care North America · Aug 2000
HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L
K994198 · Toray Industries (America), Inc. · Aug 2000