510(k) · Cleared
ClearedBerichrom Heparin LMW Calibrator, Berichrom Heparin LMW Control 1, and Berichrom Heparin LMW Control 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Jan 26, 2009 as substantially equivalent to K030964 (Instrumentation Laboratory CO, 2003) and 1 other predicate after a 91-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jan 26, 2009
- Review
- 91 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002400 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
- 1 generation backK030964 Calibration Plasma LMW HeparinInstrumentation Laboratory CO · 2003
- This deviceK083159 Berichrom Heparin LMW Calibrator, Berichrom Heparin LMW Control 1…Siemens Healthcare Diagnostics · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002400 | Modification of Acl Advance | Instrumentation Laboratory CO | 2000 | 2 |
| −1 | K030964 | Calibration Plasma LMW Heparin | Instrumentation Laboratory CO | 2003 | — |
| 0 (this device) | K083159 | Berichrom Heparin LMW Calibrator, Berichrom Heparin LMW Control 1, and… | Siemens Healthcare Diagnostics | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
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 JPA? 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 JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 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 |
|---|---|---|---|
| * | K030964 | Calibration Plasma LMW HeparinSummary page 2…II 3 Classification Panel(s) Hematology (81) 4 Product Code(s) JPA, GIZ, GGC D Predicate Device(s) Calibration Plasma LMW Heparn - K030964 Control Plasma LMW Hepann - K030965 E Device Description(s) Benchrom Heparn LMW Calibrator Benchrom Heparn LMW C… | 2003 |
| * | K030965 | Control Plasma LMW HeparinSummary page 2…Hematology (81) 4 Product Code(s) JPA, GIZ, GGC D Predicate Device(s) Calibration Plasma LMW Heparn - K030964 Control Plasma LMW Hepann - K030965 E Device Description(s) Benchrom Heparn LMW Calibrator Benchrom Heparn LMW Calibrator is a !yophilized product contai… | 2003 |
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 9 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K030964.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Benchrom Heparin LMW Calibrator is an in vitro diagnostic product used for the calibration of the Benchrom Heparin assay for measurement of low molecular weight (LMW) heparin
Benchrom Heparin LMW Control 1 is an assayed, low level, quality control material for assessment of precision and analytical bias in the quantitative determination of low molecular weight (LMW) heparin with the Berichrom Heparin assay
Berichrom Heparin LMW Control 2 is an assayed, high level, quality control material for assessment of precision and analytical bias in the quantitative determination of low molecular weight (LMW) heparin with the Berichrom Heparin assay
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083159: Berichrom Heparin LMW Calibrator, Berichrom Heparin LMW Control 1, and Berichrom Heparin LMW Control 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083159
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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