Cleared Traditional

IBC VRV, MODEL 1350 (K992657) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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

Devices cleared under the same product code (DWD) and FDA review panel - the closest regulatory comparables to K992657.
B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.
K915480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT
K915481 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT
K915482 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-
K830149 · Instrumentation Laboratory CO · Feb 1983