Cleared Traditional

K955380 - IBC QUICK CELL COMPONENT (1/2

K955380 is an FDA 510(k) clearance for IBC QUICK CELL COMPONENT (1/2, manufactured by International Biophysics Corp.. The device is a Class 2 Cardiovascular device with product code DRY cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K955380 · International Biophysics Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
172d
Days
Class 2
Risk

K955380 is an FDA 510(k) clearance for the IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4). Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by International Biophysics Corp. (Austin, US). The FDA issued a Cleared decision on May 14, 1996 after a review of 172 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4330 - 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 - K955380

510(k) Number K955380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1995
Decision Date May 14, 1996
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRY Device Classification - Class 2, Special Controls

Product Code DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4330
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 - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 25
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K955380.
3M CDI QUICK-CELLS WITH HEPARIN TREATMENT
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K973472 · 3M Healthcare · Dec 1997
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
K972962 · 3M Company · Nov 1997
CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO
K931968 · 3M Health Care, Ltd. · Nov 1993
CDI(TM) 300, 400 & 100, MODIFICATION
K915255 · 3M Company · Jan 1992
CDI(TM) H/S CUVETTE, MODIFICATION
K915265 · 3M Company · Jan 1992