Cleared Traditional

K903641 - QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND...

K903641 is the FDA 510(k) clearance for QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND... by Bentley Laboratories, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K903641 · Bentley Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1990
Decision
87d
Days
Class 2
Risk

K903641 is an FDA 510(k) clearance for the QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on November 9, 1990 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K903641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1990
Decision Date November 09, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 130d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 188
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K903641.
FRESENIUS POLYSULFONE DIALYZERS
K921134 · Fresenius USA, Inc. · Dec 1993
PERITONEAL DIALYSIS CYCLER SET
K914363 · National Medical Care, Medical Products Div., Inc. · Mar 1992
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · Abbott Laboratories · Apr 1991
HOLLOW FIBER DIALYZER, BIO CARE PS 130
K900018 · National Medical Care, Medical Products Div., Inc. · Jul 1990
GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER
K900918 · Gambro, Inc. · Jul 1990
HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H
K895759 · National Medical Care, Medical Products Div., Inc. · Nov 1989