Cleared Traditional

K853030 - TECHNICON H*1 SYSTEM (HDW)

K853030 is an FDA 510(k) clearance for TECHNICON H*1 SYSTEM (HDW), manufactured by Technicon Instruments Corp.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K853030 · Technicon Instruments Corp. · Hematology device
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Feb 1986
Decision
202d
Days
Class 2
Risk

K853030 is an FDA 510(k) clearance for the TECHNICON H*1 SYSTEM (HDW). Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on February 5, 1986 after a review of 202 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 Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K853030

510(k) Number K853030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1985
Decision Date February 05, 1986
Days to Decision 202 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 113d · This submission: 202d
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 97
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K853030.
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
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1
K853036 · Diagnostic Technology, Inc. · Nov 1985
COULTER COUNTER MODEL T-660
K854114 · Coulter Electronics, Inc. · Nov 1985
COULTER COUNTER MODEL M5
K853429 · Coulter Electronics, Inc. · Oct 1985