Cleared Traditional

ADD-A-VIAL II BINARY CONNECTOR (K900865) - FDA 510(k) Clearance

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

K900865 · Kendall Mcgaw Laboratories, Inc. · General Hospital
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Jul 1990
Decision
138d
Days
Class 2
Risk

K900865 is an FDA 510(k) clearance for the ADD-A-VIAL II BINARY CONNECTOR. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Kendall Mcgaw Laboratories, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 11, 1990 after a review of 138 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kendall Mcgaw Laboratories, Inc. devices

Submission Details

510(k) Number K900865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1990
Decision Date July 11, 1990
Days to Decision 138 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 129d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 56
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K900865.
NUTRIMIX MICROCOMPOUNDER
K921365 · Abbott Laboratories · Jun 1992
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · Abbott Laboratories · Apr 1991
RECONSTITUTION DEVICE
K910793 · Baxter Healthcare Corp · Mar 1991
NUTRIMIX MACRO TPN COMPOUNDER
K901404 · Abbott Laboratories · Jun 1990
AUTOMIX 3+3 COMPOUNDER
K894827 · Baxter Healthcare Corp · Oct 1989
MODIFIED SLIDING RECONSTITUTION DEVICE
K884626 · Baxter Healthcare Corp · Nov 1988