Cleared Traditional

K992785 - IBC FLOGUARD

K992785 is an FDA 510(k) clearance for IBC FLOGUARD, manufactured by International Biophysics Corp.. The device is a Class 2 Cardiovascular device with product code MJJ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K992785 · International Biophysics Corp. · Cardiovascular device
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Jan 2000
Decision
148d
Days
Class 2
Risk

K992785 is an FDA 510(k) clearance for the IBC FLOGUARD, MODEL 6050. Classified as Cpb Check Valve, Retrograde Flow, In-line (product code MJJ), Class II - Special Controls.

Submitted by International Biophysics Corp. (Austin, US). The FDA issued a Cleared decision on January 14, 2000 after a review of 148 days - within the typical 510(k) review window.

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: 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 - K992785

510(k) Number K992785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1999
Decision Date January 14, 2000
Days to Decision 148 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
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJJ Device Classification - Class 2, Special Controls

Product Code MJJ Cpb Check Valve, Retrograde Flow, In-line
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 - MJJ Cpb Check Valve, Retrograde Flow, In-line

Devices cleared under the same product code (MJJ) and FDA review panel - the closest regulatory comparables to K992785.
MiniGuard Arterial Safety Valve
K182442 · Quest Medical, Inc. · Nov 2018
One Way Soft Valve
K142500 · Terumo Cardiovascular Systems Corporation · Jan 2015
COBE VACUUM RELIEF CHECK VALVE
K982406 · Cobe Cardiovascular, Inc. · Oct 1998
FLOW CONROL VALVE
K922781 · American Omni Medical, Inc. · Mar 1993
FLOW CONTROL VALVE, CAT. NO. ACV-38
K922356 · American Omni Medical, Inc. · Feb 1993