Cleared Traditional

K922840 - ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE...

K922840 is an FDA 510(k) clearance for ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE..., manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K922840 · Gish Biomedical, Inc. · Cardiovascular device
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May 1993
Decision
339d
Days
Class 2
Risk

K922840 is an FDA 510(k) clearance for the ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 17, 1993 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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. Elevated predicate reliance profile. 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K922840

510(k) Number K922840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1992
Decision Date May 17, 1993
Days to Decision 339 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 125d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 85
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K922840.
ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES
K911884 · Advance Medical Designs, Inc. · Jul 1994
CHECK VALVE (FITTING)
K933084 · Merit Medical Systems, Inc. · Mar 1994
STOPCOCK (ONE-PORT MANIFOLD)
K934123 · Merit Medical Systems, Inc. · Nov 1993
PASSAGE HEMOSTASIS VALVE
K925419 · Merit Medical Systems, Inc. · Jan 1993
ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK
K915301 · Advance Medical Designs, Inc. · Dec 1992
HIGH PRESSURE CONNECTING SETS, MODIFICATION
K914987 · E-Z-Em, Inc. · May 1992