Cleared Traditional

K050195 - V-BAG WITH GBS COATING

K050195 is an FDA 510(k) clearance for V-BAG WITH GBS COATING, manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K050195 · Gish Biomedical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2005
Decision
49d
Days
Class 2
Risk

K050195 is an FDA 510(k) clearance for the V-BAG WITH GBS COATING. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Houston, US). The FDA issued a Cleared decision on March 17, 2005 after a review of 49 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K050195

510(k) Number K050195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2005
Decision Date March 17, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

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 134
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K050195.
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000
K061743 · Maquet Cardiopulmonary, AG · Jul 2006
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
K061527 · Sorin Group Italia S.R.L. · Jun 2006
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
K051606 · Gish Biomedical, Inc. · Aug 2005
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
K050111 · Cobe Cardiovascular, Inc. · Mar 2005
CAPIOX FLEXIBLE VENOUS RESERVOIR
K040023 · Terumo Cardiovascular Systems Corp. · Mar 2004
CAPIOX CARDIOTOMY RESERVOIR
K033800 · Terumo Cardiovascular Systems Corporation · Feb 2004