Cleared Traditional

K822823 - HEMATOLOGY COMPUTER-INTERFACE

K822823 is the FDA 510(k) clearance for HEMATOLOGY COMPUTER-INTERFACE by Eko Scann AB. It is a Class 2 Hematology device (product code LKM) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K822823 · Eko Scann AB · Hematology device
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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.