Cleared Traditional

CUSTOM TUBING PACKS (K913363) - FDA 510(k) Clearance

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

K913363 · Kroy Medical, Inc. · Cardiovascular device
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Dec 1991
Decision
144d
Days
Class 2
Risk

K913363 is an FDA 510(k) clearance for the CUSTOM TUBING PACKS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Kroy Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 144 days - within the typical 510(k) review window.

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. 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 Kroy Medical, Inc. devices

Submission Details

510(k) Number K913363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date December 20, 1991
Days to Decision 144 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 125d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K913363.
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
MERIT MANIFOLD
K913161 · Merit Medical Systems, Inc. · Oct 1991
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683 · 3M Company · Aug 1989
USCI TANDEM ADAPTER
K884200 · C.R. Bard, Inc. · Dec 1988