Cleared Traditional

HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT (K822823) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K822823 · Eko Scann AB · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1982
Decision
27d
Days
Class 2
Risk

K822823 is an FDA 510(k) clearance for the HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT. Classified as Counter, Urine Particle (product code LKM), Class II - Special Controls.

Submitted by Eko Scann AB (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eko Scann AB devices

Submission Details

510(k) Number K822823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1982
Decision Date October 18, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKM Counter, Urine Particle
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 - LKM Counter, Urine Particle

All 14
Devices cleared under the same product code (LKM) and FDA review panel - the closest regulatory comparables to K822823.
iQ200 Series
K252580 · Beckman Coulter, Inc. · Sep 2025
AUTION EYE AI-4510 Urine Particle Analysis System
K232416 · Arkray, Inc. · May 2024
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
K210127 · Beckman Coulter, Inc. · Jul 2021
cobas u 701 microscopy analyzer
K200811 · Roche Diagnostics · Nov 2020
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
K171883 · Sysmex America, Inc. · Apr 2018