Cleared Traditional

INTERLINK UNIVERSAL VIAL ADAPTER (K924064) - FDA 510(k) Clearance

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

K924064 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
252d
Days
Class 2
Risk

K924064 is an FDA 510(k) clearance for the INTERLINK UNIVERSAL VIAL ADAPTER. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on April 21, 1993 after a review of 252 days - an extended review cycle.

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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K924064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1992
Decision Date April 21, 1993
Days to Decision 252 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 129d · This submission: 252d
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 55
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K924064.
AUTOMIX 3+3/AS COMPOUNDER SYSTEM
K961008 · Baxter Healthcare Corp · Oct 1997
AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM
K955622 · Baxter Healthcare Corp · May 1997
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
K960466 · Abbott Laboratories · May 1996
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