Cleared Traditional

K864964 - 5 - IN - 1 CONNECTOR

K864964 is an FDA 510(k) clearance for 5 - IN - 1 CONNECTOR, manufactured by Medovations, Inc.. The device is a Class 2 General Hospital device with product code GAZ cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K864964 · Medovations, Inc. · General Hospital
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Jan 1987
Decision
29d
Days
Class 2
Risk

K864964 is an FDA 510(k) clearance for the 5 - IN - 1 CONNECTOR. Classified as Tubing, Noninvasive (product code GAZ), Class II - Special Controls.

Submitted by Medovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital device 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 - K864964

510(k) Number K864964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date January 20, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAZ Device Classification - Class 2, Special Controls

Product Code GAZ Tubing, Noninvasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - GAZ Tubing, Noninvasive

All 26
Devices cleared under the same product code (GAZ) and FDA review panel - the closest regulatory comparables to K864964.
MAXI-FLOW SUCTION SET W/Y CONNECTOR
K910171 · Adler Instrument Co. · Feb 1991
VIR-A-VAC EMPTY
K882315 · Viratec Corp. · Sep 1988
SURGICAL CONNECTING TUBES
K883473 · Westmark, Sterile Packing Systems, Inc. (Sps) · Aug 1988
5 IN 1 CONNECTOR
K861757 · Jackson Plastics, Inc. · Jun 1986
PHARMA-PLAST SMOOTH BORE CONNECTORS
K843476 · Zimmar Consulting , Ltd. · Sep 1984
MMG CONNECTIVE TUBING
K840838 · Medical Marketing Group · Mar 1984
K864964 · 5 - IN - 1 CONNECTOR
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