Cleared Traditional

K945677 - IL682, CO-OXIMETER

K945677 is an FDA 510(k) clearance for IL682, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Hematology device with product code GKR cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K945677 · Instrumentation Laboratory CO · Hematology device
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Oct 1995
Decision
336d
Days
Class 2
Risk

K945677 is an FDA 510(k) clearance for the IL682, CO-OXIMETER. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K945677

510(k) Number K945677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1994
Decision Date October 20, 1995
Days to Decision 336 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
223d slower than avg
Panel avg: 113d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKR Device Classification - Class 2, Special Controls

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 Hematology devices follow this clearance model.

Regulatory Peers - GKR System, Hemoglobin, Automated

All 28
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K945677.
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561 · International Technidyne Corp. · Jan 2003
BAYER RAPIDPOINT 405 SYSTEM
K020616 · Bayer Diagnostics Corp. · Jul 2002
HEMOCUE B-HEMOGLOBIN SYSTEM
K961312 · Hemocue, Inc. · Sep 1996
AVL OMNI ANALYZER
K954018 · Avl Scientific Corp. · Oct 1995
HEMOGLOBIN REAGENT
K910745 · Toa Medical Electronics USA, Inc. · Jul 1991
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · Ciba Corning Diagnostics Corp. · Jun 1988