510(k) · Cleared
ClearedBerichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom Heparin UF 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 K042941 (Dade Behring, Inc., 2004) after a 90-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Jan 26, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K812424 (1981). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK812424 CI-Trol Heparin Controls, Low/HighAmerican Dade · 1981
- 1 generation backK042941 Dade Behring Heparin Calibrator and ControlsDade Behring, Inc. · 2004
- This deviceK083175 Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and…Siemens Healthcare Diagnostics · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K812424 | CI-Trol Heparin Controls, Low/High | American Dade | 1981 | — |
| −1 | K042941 | Dade Behring Heparin Calibrator and Controls | Dade Behring, Inc. | 2004 | — |
| 0 (this device) | K083175 | Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom… | Siemens Healthcare Diagnostics | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 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? (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 |
|---|---|---|---|
| * | K042941 | Dade Behring Heparin Calibrator and ControlsSummary page 2…fication Panel(s) Hematology (81) 4 Product Code(s) JPA, GIZ, GGC D Predicate Device(s) Dade Behring Heparn Calibrator and Controls - K042941 E Device Descnption(s) Benchrom Heparn UF Calibrator Benchrom Hepann UF Calibrator is a lyophilized product containi… | 2004 |
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 28 years and passes through 3 companies; a new generation was cleared every 23.2 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K042941.
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?
Berichrom Heparin UF Calibrator is an in vitro diagnostic product used for the calibration of the Benchrom Heparin assay for measurement of unfractionated (UF) heparin
Berichrom Heparin UF Control 1 is an assayed, low level, quality control material for assessment of precision and analytical bias in the quantitative determination of unfractionated (UF) heparin with the Berichrom Heparin assay
Berichrom Heparin UF Control 2 is an assayed, high level, quality control material for assessment of precision and analytical bias in the quantitative determination of unfractionated (UF) heparin with the Berichrom Heparin assay
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083175: Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom Heparin UF 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/K083175
Report an extraction error
Are you the manufacturer?
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