Cleared Traditional

K914256 - YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU

K914256 is an FDA 510(k) clearance for YELLOW IRIS URINALYSIS WRKSTA W/IRISCOP..., manufactured by Intl. Remote Imaging Systems. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K914256 · Intl. Remote Imaging Systems · Hematology device
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May 1992
Decision
221d
Days
Class 2
Risk

K914256 is an FDA 510(k) clearance for the YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on May 1, 1992 after a review of 221 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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. Standard predicate reliance. 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 Intl. Remote Imaging Systems devices

FDA 510(k) Submission Details - K914256

510(k) Number K914256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1991
Decision Date May 01, 1992
Days to Decision 221 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 113d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 98
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