Cleared Traditional

K841803 - A1 SYSTEME 8201/2

K841803 is an FDA 510(k) clearance for A1 SYSTEME 8201/2, manufactured by Med USA. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K841803

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.

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 K841803.
COULTER CHANNELYZER 256
K851736 · Coulter Electronics, Inc. · Jul 1985
SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS
K850171 · Toa Medical Electronics USA, Inc. · May 1985
CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER
K845019 · Abbott Diagnostics · Mar 1985
COULTER COUNTER MODEL M4
K843303 · Coulter Electronics, Inc. · Dec 1984
COULTER COUNTER MODEL ZM
K843164 · Coulter Electronics, Inc. · Nov 1984
BLOOD DILUTION VIAL
K844042 · American Scientific Products · Oct 1984