Cleared Traditional

K913692 - VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)

K913692 is the FDA 510(k) clearance for VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) by Bentley Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K913692 · Bentley Laboratories, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
88d
Days
Class 2
Risk

K913692 is an FDA 510(k) clearance for the VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM). Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on November 15, 1991 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight 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 K913692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date November 15, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 126
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K913692.
NEW COBE CARDIOPLEGIA SYSTEM
K920312 · Cobe Cardiovascular, Inc. · Oct 1992
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
K915737 · Electromedics, Inc. · Sep 1992
BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30
K913956 · Bentley Laboratories, Inc. · Jan 1992
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790 · Medtronic Vascular · Aug 1991
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K911876 · Shiley, Inc. · Aug 1991
COBE ICU CONVERSION KIT
K902631 · Cobe Laboratories, Inc. · Dec 1990