510(k) · Cleared
ClearedHCT Extended Hematology Control, Model HCT004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R&D Systems, Inc. · JPK Mixture, Hematology Quality Control
Cleared on Dec 27, 2007 as substantially equivalent to K843962 (R&D Systems, Inc., 1984) after a 44-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Dec 27, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- JPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K843962 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK843962 CBC-PLT-4 Whole Blood Control/MultipleR&D Systems, Inc. · 1984 · Recalled
- This deviceK073178 HCT Extended Hematology Control, Model HCT004R&D Systems, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843962 | CBC-PLT-4 Whole Blood Control/Multiple | R&D Systems, Inc. | 1984 | 3 |
| 0 (this device) | K073178 | HCT Extended Hematology Control, Model HCT004 | R&D Systems, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K843962 | CBC-PLT-4 Whole Blood Control/MultipleSummary page 1…ality Control Mixture Product Code: JPK Device Class: II Panel: Hematology (81) Predicate Device R&D Systems CBC-7 Hematology Control (K843962) Description of Device HCT Extended Hematology Control is an in vitro diagnostic reagent composed of human erythrocytes suspende… | 1984 |
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 a recall.
- 1 other device also cites its predicate K843962.
How does its category compare?
All JPK devicesJPK Mixture, Hematology Quality Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
It is an established laboratory procedure to use a stable control to monitor the performance of diagnostic tests. HCT Extended Hematology Control is an assayed control designed to monitor values obtained from automated, semi-automated and manual methods.
For in vitro Diagnostic Use Only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073178 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073178: HCT Extended Hematology Control, Model HCT004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073178
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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