Cleared Traditional

K874207 - THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION

K874207 is an FDA 510(k) clearance for THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKS..., manufactured by Intl. Remote Imaging Systems. The device is a Class 1 Pathology device with product code IBJ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K874207 · Intl. Remote Imaging Systems · Pathology device
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Jan 1988
Decision
82d
Days
Class 1
Risk

K874207 is an FDA 510(k) clearance for the THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION. Classified as Light, Microscope (product code IBJ), Class I - General Controls.

Submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3600 - the FDA pathology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K874207

510(k) Number K874207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1987
Decision Date January 05, 1988
Days to Decision 82 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 78d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

IBJ Device Classification - Class 1, General Controls

Product Code IBJ Light, Microscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3600
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IBJ Light, Microscope

All 8
Devices cleared under the same product code (IBJ) and FDA review panel - the closest regulatory comparables to K874207.
VIDEO ANALYZER 4000
K874750 · Scientific Imaging, Inc. · Apr 1988
CELL COUNTING GRID GRATICULE
K874190 · Portable Medical Laboratories, Inc. · Jan 1988
MCARTHUR MICROSCOPE, STANDARD METAL VERSION
K864049 · Portable Medical Laboratories, Inc. · Oct 1986
MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.
K854735 · Portable Medical Laboratories, Inc. · Dec 1985
PATHOLOGY INSTRUMENTATION & ACCESSORIES
K823040 · Iris Remote Imaging Systems · Jan 1983
2XC MICROSCOPE
K822207 · Amarel Precision Instruments, Inc. · Aug 1982
K874207 · THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION
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