Cleared Traditional

K863402 - MEDI-PLAST DISPOSABLE MANIFOLD

K863402 is an FDA 510(k) clearance for MEDI-PLAST DISPOSABLE MANIFOLD, manufactured by Medi-Plast Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K863402 · Medi-Plast Intl., Inc. · Cardiovascular device
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Oct 1986
Decision
49d
Days
Class 2
Risk

K863402 is an FDA 510(k) clearance for the MEDI-PLAST DISPOSABLE MANIFOLD. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Medi-Plast Intl., Inc. (Atlanta, US). The FDA issued a Cleared decision on October 22, 1986 after a review of 49 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K863402

510(k) Number K863402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date October 22, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
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 126
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K863402.
#014160-TAB TUBING ROTATOR ADAPTOR
K870325 · Clinical Connections, Inc. · Apr 1987
MANIFOLD SWIVEL ROTATOR MODELS 014320 & 014321-TAB
K870073 · Clinical Connections, Inc. · Feb 1987
LUER LOCK SKIRT
K862451 · Hewlett-Packard Co. · Oct 1986
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
K863177 · Cordis Corp. · Oct 1986
MEDCOMP DISPOSABLE MANIFOLD SYSTEM
K863661 · Medical Components, Inc. · Sep 1986
DISPOSABLE STOPCOCK
K861783 · Utah Medical Products, Inc. · Jul 1986
K863402 · MEDI-PLAST DISPOSABLE MANIFOLD
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