Cleared Traditional

QTMICRO(TM) SYSTEM (K950305) - FDA 510(k) Clearance

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

K950305 · Q.I. Medical, Inc. · General Hospital
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Oct 1995
Decision
261d
Days
Class 2
Risk

K950305 is an FDA 510(k) clearance for the QTMICRO(TM) 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 October 13, 1995 after a review of 261 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 Q.I. Medical, Inc. devices

Submission Details

510(k) Number K950305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1995
Decision Date October 13, 1995
Days to Decision 261 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
132d slower than avg
Panel avg: 129d · This submission: 261d
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 64
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K950305.
COMBIPROT EMERGENCY ENFUSION DEVICE
K970359 · B.Braun Medical, Inc. · Mar 1997
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION)
K960466 · Abbott Laboratories · May 1996
FORMULATION PREPARATION DEVICE
K955398 · B.Braun Medical, Inc. · Apr 1996
INTERLINK UNIVERSAL VIAL ADAPTER
K924064 · Baxter Healthcare Corp · Apr 1993
NUTRIMIX MICROCOMPOUNDER
K921365 · Abbott Laboratories · Jun 1992
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · Abbott Laboratories · Apr 1991