510(k) · Cleared
ClearedDade Behring Heparin Calibrator and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · GIZ Plasma, Control, Normal
Cleared on Dec 2, 2004 as substantially equivalent to K843202 (E.I. Dupont DE Nemours & Co., Inc., 1984) and 1 other predicate after a 38-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.
- Decided
- Dec 2, 2004
- Review
- 38 days
- Class
- Class II
- Product code
- GIZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K812424 (1981). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK812424 CI-Trol Heparin Controls, Low/HighAmerican Dade · 1981
- This deviceK042941 Dade Behring Heparin Calibrator and ControlsDade Behring, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK083175 Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and…Siemens Healthcare Diagnostics · 2009
- Descendant · cites it directly · 0 of its ownK051472 Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin…Hyphen Biomed · 2005 · Recalled
Most influential descendants
Showing 2 of 2 · See all- K083175Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom Heparin…Siemens Healthcare Diagnostics · 2009 · cites it directly0descendants
- K051472Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh CalibratorHyphen Biomed · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K812424 | CI-Trol Heparin Controls, Low/High | American Dade | 1981 | — |
| 0 (this device) | K042941 | Dade Behring Heparin Calibrator and Controls | Dade Behring, Inc. | 2004 | — |
| +1 | K083175 | Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom… | Siemens Healthcare Diagnostics | 2009 | — |
| +1 | K051472 | Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh… | Hyphen Biomed | 2005 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 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 GIZ? 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? (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 |
|---|---|---|---|
| * | K843202 | Heparin Calibrator AcaSummary page 1…ose system for in vitro coagulation studies, Class 11 (864.5425) 3. Identification of the Legally Marketed Device: aca® Heparin Calibrator (K843202) Ci-Trol® Heparin Controls, Low and High (K812424) 4. Device Description: Dade Behring Heparin Cali… | 1984 |
| * | K812424 | CI-Trol Heparin Controls, Low/HighSummary page 1…11 (864.5425) 3. Identification of the Legally Marketed Device: aca® Heparin Calibrator (K843202) Ci-Trol® Heparin Controls, Low and High (K812424) 4. Device Description: Dade Behring Heparin Calibrator and Controls are lyophilized products prepa… | 1981 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K083175 (Siemens Healthcare Diagnostics, 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GIZ devicesGIZ Plasma, Control, Normal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GIZ
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GIZ
Too few GIZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GIZ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIZ
No MAUDE report names GIZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 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?
The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to
calibrate the Berichrom® Heparin assay for the measurement of unfractionated
heparin. Dade Behring Heparin Controls are in vitro diagnostic products
intended to be used as assayed, unfractionated heparin quality control materials
for the Berichrom® Heparin assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042941: Dade Behring Heparin Calibrator and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042941
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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