Cleared Traditional

K854677 - ERMA PC-604 BLOOD CELL COUNTER

K854677 is an FDA 510(k) clearance for ERMA PC-604 BLOOD CELL COUNTER, manufactured by Future Impex Corp.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K854677 · Future Impex Corp. · Hematology device
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Feb 1986
Decision
96d
Days
Class 2
Risk

K854677 is an FDA 510(k) clearance for the ERMA PC-604 BLOOD CELL COUNTER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Future Impex Corp. (Deerpark, US). The FDA issued a Cleared decision on February 24, 1986 after a review of 96 days - within the typical 510(k) review window.

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 Future Impex Corp. devices

FDA 510(k) Submission Details - K854677

510(k) Number K854677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1985
Decision Date February 24, 1986
Days to Decision 96 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 113d · This submission: 96d
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 99
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K854677.
COULTER COUNTER MODEL S PLUS JUNIOR
K861780 · Coulter Electronics, Inc. · Aug 1986
PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
K860586 · Diagnostic Technology, Inc. · May 1986
PICOSCALE BLOOD CELL COUNTER, MODEL PS-5
K860166 · Diagnostic Technology, Inc. · Apr 1986
TECHNICON H*1 SYSTEM (HDW)
K853030 · Technicon Instruments Corp. · Feb 1986
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
K853036 · Diagnostic Technology, Inc. · Nov 1985
COULTER COUNTER MODEL T-660
K854114 · Coulter Electronics, Inc. · Nov 1985