Cleared Traditional

K812009 - CARDIOTOMY RESERVOIR W/FILTER#BCR-3500

K812009 is the FDA 510(k) clearance for CARDIOTOMY RESERVOIR W/FILTER#BCR-3500 by Bentley Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K812009 · Bentley Laboratories, Inc. · Cardiovascular device
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Jul 1981
Decision
11d
Days
Class 2
Risk

K812009 is an FDA 510(k) clearance for the CARDIOTOMY RESERVOIR W/FILTER#BCR-3500. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 11 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 K812009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1981
Decision Date July 28, 1981
Days to Decision 11 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
114d faster than avg
Panel avg: 125d · This submission: 11d
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 K812009.
SC-2500F CARDIOTOMY RESERVIOR
K813268 · Scimed Life Systems, Inc. · May 1982
SUCKER CARDIOTOMY RETURN, C.P. BYPASS
K812455 · Electromedics, Inc. · Oct 1981
CORDIOTOMY RESERVOIR
K812008 · Bentley Laboratories, Inc. · Jul 1981
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER
K803059 · Extracorporeal Medical Specialities, Inc. · Dec 1980
SHILEY UTILITY RESERVOIR
K802119 · Shiley, Inc. · Sep 1980
Q220F CARDITOMY RESERVOIR/MODIFIED
K790635 · Bentley Laboratories, Inc. · Apr 1979