510(k) · Cleared
ClearedAthelas Home
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Athelas, Inc. · GKZ Counter, Differential Cell
Cleared on Feb 6, 2026 as substantially equivalent to K200828 (Athelas, Inc., 2022) and 1 other predicate after a 466-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Feb 6, 2026
- Review
- 466 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K040073 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK040073 Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100…Sysmex America, Inc. · 2004
- 3 generations backK071967 Sysmex XE-5000Sysmex America, Inc. · 2007 · Recalled
- 2 generations backK181288 Athelas OneAthelas, Inc. · 2018
- 1 generation backK200828 Athelas HomeAthelas, Inc. · 2022
- This deviceK243348 Athelas HomeAthelas, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L) | Sysmex America, Inc. | 2004 | — |
| −3 | K071967 | Sysmex XE-5000 | Sysmex America, Inc. | 2007 | 1 |
| −2 | K181288 | Athelas One | Athelas, Inc. | 2018 | — |
| −1 | K200828 | Athelas Home | Athelas, Inc. | 2022 | — |
| 0 (this device) | K243348 | Athelas Home | Athelas, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200828 | Athelas HomeSummary page 5…KZ) Type of Test or Tests Performed: WBC and NEUT% on Whole Blood (venous K2EDTA and capillary whole blood). Identical to predicate Athelas One K181288 and Athelas Home K200828 for home-use indication. Indicated use: The Athelas Home is indicated for the quantitative determination of white blood cells (W… | 2022 |
| * | K181288 | Athelas OneSummary page 5…864.5220, Product Code GKZ) Type of Test or Tests Performed: WBC and NEUT% on Whole Blood (venous K2EDTA and capillary whole blood). Identical to predicate Athelas One K181288 and Athelas Home K200828 for home-use indication. Indicated use: The Athelas Home is indicated for the quantitative determinatio… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
The Athelas Home is indicated for the quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary whole blood from fingerstick for patient self-testing with results viewable by healthcare professionals, and in capillary or K2EDTA venous whole blood for multiple-patient use in point-of-care settings. For self-testing, the Athelas Home is intended to be used by a single person and should not be shared. The Athelas…
Read the full statement (164 words)
The Athelas Home is indicated for the quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary whole blood from fingerstick for patient self-testing with results viewable by healthcare professionals, and in capillary or K2EDTA venous whole blood for multiple-patient use in point-of-care settings. For self-testing, the Athelas Home is intended to be used by a single person and should not be shared. The Athelas Home is only to be used with Athelas Test Strips. The Athelas Home is intended for adult patients (aged 21 and older) at risk of neutropenia. For self-testing patients with psychiatric conditions, clinical judgment should be exercised when deciding the end-user and based on the instructions for use (IFU), the treating physician should determine which patients are competent to perform the test by themselves. Results obtained with the Athelas Home should not be the sole basis for patient diagnosis, treatment, or management of leukopenia and neutropenia, and all results should be evaluated by a healthcare provider.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243348 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243348: Athelas Home.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243348
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026