Cleared Traditional

K843639 - ADD-A-VIAL SOLUTION TRANSFER DEVICE

K843639 is an FDA 510(k) clearance for ADD-A-VIAL SOLUTION TRANSFER DEVICE, manufactured by American Mcgaw. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K843639 · American Mcgaw · General Hospital
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Jan 1985
Decision
119d
Days
Class 2
Risk

K843639 is an FDA 510(k) clearance for the ADD-A-VIAL SOLUTION TRANSFER DEVICE. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by American Mcgaw (Santa Ana, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 119 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 American Mcgaw devices

FDA 510(k) Submission Details - K843639

510(k) Number K843639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date January 14, 1985
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
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 143
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K843639.
FLOW EASE(PLASTIC VENTED NEEDLE)
K853212 · Acacia, Inc. · Sep 1985
TRANSFER DEVICE
K853188 · Advance Medical Designs, Inc. · Aug 1985
TANDEM SETS I.V.
K850757 · Acacia, Inc. · Apr 1985
TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP
K844340 · Travenol Laboratories, S.A. · Jan 1985
ACKRAD FLUID CONNECTING SET
K820937 · Ackrad Laboratories · Apr 1982
VACU-FIL TRANSFER SET
K812928 · American Pharmaseal Div. Ahsc · Dec 1981