510(k) · Cleared
ClearedMedica Easyqc Hematocrit Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionostics, Inc. · GLK Control, Hematocrit
Cleared on Jun 24, 2002 as substantially equivalent to K955630 (Bionostics, Inc., 1996) after a 13-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jun 24, 2002
- Review
- 13 days
- Class
- Class II
- Product code
- GLK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955630 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955630 Rna Medical Hemat ControlBionostics, Inc. · 1996
- This deviceK021924 Medica Easyqc Hematocrit ControlBionostics, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955630 | Rna Medical Hemat Control | Bionostics, Inc. | 1996 | — |
| 0 (this device) | K021924 | Medica Easyqc Hematocrit Control | Bionostics, Inc. | 2002 | — |
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 GLK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K955630 | Rna Medical Hemat ControlSummary page 1…Modified Device Name: RNA QC900 Hematocrit Control Medica EasyQC Hematocrit 510(k), Date: K955630 Number of levels: 2 2 Analytes: Hematocrit… | 1996 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K955630.
How does its category compare?
All GLK devicesGLK Control, Hematocrit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GLK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · GLK
Too few GLK 510(k)s in any year since 2007 to give a median.
Recalls per year · GLK
No recall names GLK since 2007.
Adverse event reports per year · GLK
1in 2020
MAUDE reports naming product code GLK, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Medica EasyQC Hematocrit Control assayed controls are intended to be used to monitor and evaluate the analytical performance of the Medica EasyStat for the measurement of hematocrit by conductivity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021924 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021924: Medica Easyqc Hematocrit Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021924
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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