Cleared Traditional

K992657 - IBC VRV

K992657 is an FDA 510(k) clearance for IBC VRV, manufactured by International Biophysics Corp.. The device is a Class 2 Cardiovascular device with product code DWD cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K992657 · International Biophysics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
193d
Days
Class 2
Risk

K992657 is an FDA 510(k) clearance for the IBC VRV, MODEL 1350. Classified as Suction Control, Intracardiac, Cardiopulmonary Bypass (product code DWD), Class II - Special Controls.

Submitted by International Biophysics Corp. (Austin, US). The FDA issued a Cleared decision on February 18, 2000 after a review of 193 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4430 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all International Biophysics Corp. devices

FDA 510(k) Submission Details - K992657

510(k) Number K992657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1999
Decision Date February 18, 2000
Days to Decision 193 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 125d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWD Device Classification - Class 2, Special Controls

Product Code DWD Suction Control, Intracardiac, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4430
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 - DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

All 12
Devices cleared under the same product code (DWD) and FDA review panel - the closest regulatory comparables to K992657.
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B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT
K915482 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
MEDISEAL SUCTION CANISTER
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K863593 · 3M Health Care, Sarns · Nov 1986