Cleared Traditional

K900865 - ADD-A-VIAL II BINARY CONNECTOR

K900865 is an FDA 510(k) clearance for ADD-A-VIAL II BINARY CONNECTOR, manufactured by Kendall Mcgaw Laboratories, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K900865

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.

LHI Device Classification - Class 2, Special Controls

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 73
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