Cleared Traditional

K012942 - THE V BAG

Also marketed or referenced as:
VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500

K012942 is the FDA 510(k) clearance for THE V BAG by Circulatory Technology, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K012942 · Circulatory Technology, Inc. · Cardiovascular device
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Nov 2001
Decision
66d
Days
Class 2
Risk

K012942 is an FDA 510(k) clearance for the THE V BAG, CATALOG NUMBER VB1800. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Circulatory Technology, Inc. (Oyster Bay, US). The FDA issued a Cleared decision on November 5, 2001 after a review of 66 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 Circulatory Technology, Inc. devices

Submission Details

510(k) Number K012942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2001
Decision Date November 05, 2001
Days to Decision 66 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 125d · This submission: 66d
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 76
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K012942.
V-BAG WITH GBS COATING
K050195 · Gish Biomedical, Inc. · Mar 2005
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
K030726 · Gish Biomedical, Inc. · May 2003
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K024065 · Gish Biomedical, Inc. · Mar 2003
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864 · Medtronic Vascular · Jul 2001
CAPIOX SX10 HARDSHELL RESEVOIR
K991973 · Terumo Medical Corp. · Sep 1999
CAPIOX SX HARDSHELL RESEVOIR
K982223 · Terumo Medical Corp. · Sep 1998