Cleared Traditional

K950305 - QTMICRO(TM) SYSTEM

K950305 is an FDA 510(k) clearance for QTMICRO(TM) 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 261-day FDA review.

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

FDA 510(k) Submission Details - K950305

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.

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 K950305.
SAFELINE I.V. BAG ACCESS DEVICE
K955594 · Mcgaw, Inc. · Mar 1996
SAFELINE MULTIDOSE VIAL ADAPTER
K955595 · Mcgaw, Inc. · Mar 1996
MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
K955896 · Critical Device Corp. · Feb 1996
DISPENSING PIN WITH ONE-WAY VALVE
K943181 · B. Braun of America, Inc. · Sep 1994
TRANSFER SET
K935532 · Puritas Health Care, Inc. · Apr 1994
DIPRIVAN LUER CONNECTOR
K935274 · Ohmeda Medical · Mar 1994