Cleared Traditional

K842373 - VENOUS RESERVOIR-BMR-1500-HARD SHELL

K842373 is an FDA 510(k) clearance for VENOUS RESERVOIR-BMR-1500-HARD SHELL, manufactured by American Bentley. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K842373 · American Bentley · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
195d
Days
Class 2
Risk

K842373 is an FDA 510(k) clearance for the VENOUS RESERVOIR-BMR-1500-HARD SHELL. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by American Bentley (Walker, US). The FDA issued a Cleared decision on December 27, 1984 after a review of 195 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4230 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all American Bentley devices

FDA 510(k) Submission Details - K842373

510(k) Number K842373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1984
Decision Date December 27, 1984
Days to Decision 195 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 125d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTP Device Classification - Class 2, Special Controls

Product Code DTP Defoamer, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4230
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 - DTP Defoamer, Cardiopulmonary Bypass

All 31
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K842373.
SHILEY 3L CARDIOTOMY RESERVOIR
K853503 · Shiley, Inc. · Nov 1985
CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX
K851004 · Gish Biomedical, Inc. · May 1985
POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE
K844803 · Electromedics, Inc. · Apr 1985
SCIMED MODEL SC4000
K840610 · Scimed Life Systems, Inc. · Apr 1984
CARDIOTOMY RESERVOIR SC3500F
K834041 · Scimed Life Systems, Inc. · Jan 1984
SHILEY 3L CARDF PLUS
K832811 · Shiley, Inc. · Sep 1983