Cleared Traditional

K841803 - A1 SYSTEME 8201/2

K841803 is the FDA 510(k) clearance for A1 SYSTEME 8201/2 by Med USA. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K841803 · Med USA · Hematology device
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Feb 1985
Decision
300d
Days
Class 2
Risk

K841803 is an FDA 510(k) clearance for the A1 SYSTEME 8201/2. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Med USA (Waltham, US). The FDA issued a Cleared decision on February 25, 1985 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Med USA devices

Submission Details

510(k) Number K841803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1984
Decision Date February 25, 1985
Days to Decision 300 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 113d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 47
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K841803.
COULTER COUNTER MODEL M5
K853429 · Coulter Electronics, Inc. · Oct 1985
COULTER VOLUME ADAPTER
K851943 · Coulter Electronics, Inc. · Aug 1985
COULTER CHANNELYZER 256
K851736 · Coulter Electronics, Inc. · Jul 1985
COULTER COUNTER MODEL M4
K843303 · Coulter Electronics, Inc. · Dec 1984
COULTER COUNTER MODEL ZM
K843164 · Coulter Electronics, Inc. · Nov 1984
COULTER AUTOMATIC SAMPLE HANDLER
K842346 · Coulter Electronics, Inc. · Jul 1984