Cleared Traditional

K970739 - RMI HEMOCONCENTRATOR PREFERENCE PACK

K970739 is an FDA 510(k) clearance for RMI HEMOCONCENTRATOR PREFERENCE PACK, manufactured by Research Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K970739 · Research Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
130d
Days
Class 2
Risk

K970739 is an FDA 510(k) clearance for the RMI HEMOCONCENTRATOR PREFERENCE PACK. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Research Medical, Inc. (Midvale, US). The FDA issued a Cleared decision on July 8, 1997 after a review of 130 days - within the typical 510(k) review window.

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 Research Medical, Inc. devices

FDA 510(k) Submission Details - K970739

510(k) Number K970739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1997
Decision Date July 08, 1997
Days to Decision 130 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
1d faster than avg
Panel avg: 131d · This submission: 130d
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 249
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K970739.
CAPIOX HEMOCONCENTRATOR
K973516 · Terumo Medical Corp. · Jan 1998
BLOOD MONITOR PUMP
K970591 · Baxter Healthcare Corp · Sep 1997
BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT
K971180 · C.R. Bard, Inc. · Jul 1997
2008H ON LINE CLEARANCE MONITOR
K961465 · Fresenius USA, Inc. · Jul 1997
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
K970446 · Althin Medical AB an Affiliate of Baxter Intl · Jun 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM
K964922 · Althin Medical AB an Affiliate of Baxter Intl · May 1997