Cleared Traditional

Athelas Home (K200828) - FDA 510(k) Clearance

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

K200828 · Athelas, Inc. · Hematology device
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Mar 2022
Decision
722d
Days
Class 2
Risk

K200828 is an FDA 510(k) clearance for the Athelas Home. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Athelas, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 22, 2022 after a review of 722 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Athelas, Inc. devices

Submission Details

510(k) Number K200828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2020
Decision Date March 22, 2022
Days to Decision 722 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
609d slower than avg
Panel avg: 113d · This submission: 722d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 126
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K200828.
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