Cleared Traditional

K954987 - ALTRATOUCH 1000 HEMODIALYSIS DELIVERY S...

K954987 is an FDA 510(k) clearance for ALTRATOUCH 1000 HEMODIALYSIS DELIVERY S..., manufactured by Althin Medical AB an Affiliate of Baxter Intl. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K954987 · Althin Medical AB an Affiliate of Baxter Intl · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
282d
Days
Class 2
Risk

K954987 is an FDA 510(k) clearance for the ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Althin Medical AB an Affiliate of Baxter Intl (Portland, US). The FDA issued a Cleared decision on August 8, 1996 after a review of 282 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 Althin Medical AB an Affiliate of Baxter Intl devices

FDA 510(k) Submission Details - K954987

510(k) Number K954987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1995
Decision Date August 08, 1996
Days to Decision 282 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
152d slower than avg
Panel avg: 130d · This submission: 282d
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 216
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K954987.
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
K963203 · Baxter Healthcare Corp · Mar 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION
K955384 · Althin Medical AB an Affiliate of Baxter Intl · Jan 1997
MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET
K962707 · Minntech Corp. · Oct 1996
ALTRA FLUX 110 HEMODIALYZER
K952978 · Althin Medical AB an Affiliate of Baxter Intl · Oct 1995
ALTREX 110 HEMODIALYZER
K952982 · Althin Medical AB an Affiliate of Baxter Intl · Oct 1995
ALTR NOVA 110 HEMODIALYZER
K952983 · Althin Medical AB an Affiliate of Baxter Intl · Oct 1995