Cleared Traditional

K855049 - MODIFIED MODEL SC4000(F) CARDIOTOMY RES...

K855049 is the FDA 510(k) clearance for MODIFIED MODEL SC4000(F) CARDIOTOMY RES... by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DTP) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K855049 · Scimed Life Systems, Inc. · Cardiovascular device
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Feb 1986
Decision
71d
Days
Class 2
Risk

K855049 is an FDA 510(k) clearance for the MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 71 days - a notably fast clearance 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: 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 Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K855049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1985
Decision Date February 26, 1986
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 28
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K855049.
CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500
K872167 · American Bentley · Sep 1987
THORASTAT ATR-XXXX
K870792 · Gish Biomedical, Inc. · Apr 1987
SARNS FILTERED CARDIOTOMY RESERVOIR
K860702 · 3M Health Care, Sarns · May 1986
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