510(k) · Cleared
ClearedLiquichek Hematology-16 Control LV, Model: 295LV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · JPK Mixture, Hematology Quality Control
Cleared on Aug 2, 2010 as substantially equivalent to K902389 (Hematronix, Inc., 1990) after a 455-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Aug 2, 2010
- Review
- 455 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902389 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902389 Tri-Count 16Hematronix, Inc. · 1990
- This deviceK091303 Liquichek Hematology-16 Control LV, Model: 295LVBio-Rad Laboratories · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902389 | Tri-Count 16 | Hematronix, Inc. | 1990 | — |
| 0 (this device) | K091303 | Liquichek Hematology-16 Control LV, Model: 295LV | Bio-Rad Laboratories | 2010 | — |
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 JPK? 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 |
|---|---|---|---|
| * | K902389 | Tri-Count 16Summary page 1…S Control (formerly known as TRI-COUNT 16) Bio-Rad Laboratories (formerly known as Hematronix, Inc.) Benicia, CA 94510 510 (k) Number: K902389 4.0 Description of Device This product is a suspension of stabilized lysable human erythrocytes, simulated p… | 1990 |
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.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JPK
4in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JPK
296in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPK
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPK
2in 2023
MAUDE reports naming product code JPK, 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 | 5 | 44 | 1 | 14 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 5 | 187 | 0 | 0 |
| 2010 | 4 | 267 | 2 | 5 |
| 2011 | 1 | — | 3 | 56 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 4 | 296 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 2 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Liquichek Hematology-16 Control LV Is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), WBC (White Blood Cells).
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/K091303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091303: Liquichek Hematology-16 Control LV, Model: 295LV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091303
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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