Cleared Traditional

K011269 - LIFEMATE MLA MULTI-LINE ADAPTOR

Also marketed or referenced as:
LIFEMATE SFR STERILE FLUID RESERVOIR

K011269 is an FDA 510(k) clearance for LIFEMATE MLA MULTI-LINE ADAPTOR, 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 312-day FDA review.

K011269 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
312d
Days
Class 2
Risk

K011269 is an FDA 510(k) clearance for the LIFEMATE MLA MULTI-LINE ADAPTOR. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on March 4, 2002 after a review of 312 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K011269

510(k) Number K011269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2001
Decision Date March 04, 2002
Days to Decision 312 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
182d slower than avg
Panel avg: 130d · This submission: 312d
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 K011269.
DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION
K021732 · Dideco S.P.A. · Nov 2002
PRISMA SYSTEM
K010805 · Gambro Renal Products · Aug 2002
NXSTAGE THERAPY SYSTEM
K020858 · Nxstage Medical, Inc. · Apr 2002
CLIRANS E-SERIES DIALYZER
K013550 · Terumo Medical Corp. · Nov 2001
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
K011221 · Gambro Renal Products · Oct 2001
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
K012510 · Nxstage Medical, Inc. · Oct 2001