Cleared Traditional

K951344 - RMI HEMOCONCENTRATOR

K951344 is an FDA 510(k) clearance for RMI HEMOCONCENTRATOR, 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 144-day FDA review.

K951344 · Research Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
144d
Days
Class 2
Risk

K951344 is an FDA 510(k) clearance for the RMI HEMOCONCENTRATOR. 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 August 15, 1995 after a review of 144 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 - K951344

510(k) Number K951344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1995
Decision Date August 15, 1995
Days to Decision 144 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
13d slower than avg
Panel avg: 131d · This submission: 144d
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 K951344.
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
FILTRYZER
K942681 · Toray Industries (America), Inc. · Jun 1995
ALTRA NOVA(TM) 170 HEMODIALYZER
K945621 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
ALTRA NOVA(TM) 140 HEMODIALYZER
K945625 · Althin Medical AB an Affiliate of Baxter Intl · May 1995