Cleared Traditional

K862357 - MODIFIED CARDIOTOMY RESERVOIR 5M1470

K862357 is the FDA 510(k) clearance for MODIFIED CARDIOTOMY RESERVOIR 5M1470 by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K862357 · 3M Health Care, Sarns · Cardiovascular device
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Aug 1986
Decision
57d
Days
Class 2
Risk

K862357 is an FDA 510(k) clearance for the MODIFIED CARDIOTOMY RESERVOIR 5M1470. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 57 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 3M Health Care, Sarns devices

Submission Details

510(k) Number K862357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1986
Decision Date August 19, 1986
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 128
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K862357.
SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR
K870829 · 3M Health Care, Sarns · May 1987
INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER
K864895 · Johnson & Johnson Professionals, Inc. · Feb 1987
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K862920 · C.R. Bard, Inc. · Sep 1986
SHILEY VENOUS RESERVOIR
K854841 · Shiley, Inc. · Feb 1986
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR
K852382 · American Bentley · Sep 1985
VENOUS RESERVOIR BAG BMR-1600
K851376 · American Bentley · Jun 1985