Cleared Traditional

K851004 - CARDIOTOMY RESERVOIR BRS-XXX & HOLDER B...

K851004 is an FDA 510(k) clearance for CARDIOTOMY RESERVOIR BRS-XXX & HOLDER B..., manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K851004 · Gish Biomedical, Inc. · Cardiovascular device
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May 1985
Decision
65d
Days
Class 2
Risk

K851004 is an FDA 510(k) clearance for the CARDIOTOMY RESERVOIR BRS-XXX & HOLDER BRS-HXX. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 16, 1985 after a review of 65 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K851004

510(k) Number K851004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date May 16, 1985
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 29
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K851004.
SARNS FILTERED CARDIOTOMY RESERVOIR
K860702 · 3M Health Care, Sarns · May 1986
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
K855049 · Scimed Life Systems, Inc. · Feb 1986
SHILEY 3L CARDIOTOMY RESERVOIR
K853503 · Shiley, Inc. · Nov 1985
POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE
K844803 · Electromedics, Inc. · Apr 1985
VENOUS RESERVOIR-BMR-1500-HARD SHELL
K842373 · American Bentley · Dec 1984
SCIMED MODEL SC4000
K840610 · Scimed Life Systems, Inc. · Apr 1984