Cleared Special

K012510 - MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM

K012510 is an FDA 510(k) clearance for MODIFICATION TO: LIFEMATE HEMOFILTRATIO..., manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Special 510(k) pathway after a 74-day FDA review.

K012510 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
74d
Days
Class 2
Risk

K012510 is an FDA 510(k) clearance for the MODIFICATION TO: 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. (Lawrence, US). The FDA issued a Cleared decision on October 19, 2001 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nxstage Medical, Inc. devices

FDA 510(k) Submission Details - K012510

510(k) Number K012510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date October 19, 2001
Days to Decision 74 days
Submission Type Special
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
56d faster than avg
Panel avg: 130d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

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 K012510.
LIFEMATE MLA MULTI-LINE ADAPTOR
K011269 · Nxstage Medical, Inc. · Mar 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
TORAYSULFONE DIALYZER
K002512 · Toray Industries (America), Inc. · Oct 2001
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
K010985 · Gambro Renal Products · Oct 2001
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
K010667 · Gambro Renal Products · Jun 2001