Cleared Traditional

K920015 - QUICKTEST SYSTEM

K920015 is an FDA 510(k) clearance for QUICKTEST SYSTEM, manufactured by Q.I. Medical, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 326-day FDA review.

K920015 · Q.I. Medical, Inc. · General Hospital
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Nov 1992
Decision
326d
Days
Class 2
Risk

K920015 is an FDA 510(k) clearance for the QUICKTEST SYSTEM. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Q.I. Medical, Inc. (Nevada City, US). The FDA issued a Cleared decision on November 23, 1992 after a review of 326 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Q.I. Medical, Inc. devices

FDA 510(k) Submission Details - K920015

510(k) Number K920015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date November 23, 1992
Days to Decision 326 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 129d · This submission: 326d
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 149
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K920015.
DIPRIVAN LUER CONNECTOR
K935274 · Ohmeda Medical · Mar 1994
INTERLINK UNIVERSAL VIAL ADAPTER
K924064 · Baxter Healthcare Corp · Apr 1993
IV FLUID TRANSFER PIN
K925401 · B. Braun of America, Inc. · Mar 1993
NUTRIMIX MICROCOMPOUNDER
K921365 · Abbott Laboratories · Jun 1992
ACACIAS PHARM/PUMP
K912771 · Acacia, Inc. · Feb 1992
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · Abbott Laboratories · Apr 1991