510(k) · Cleared
ClearedCI-Trol Heparin Controls, Low/High
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Dade · KFF Assay, Heparin
Cleared on Oct 2, 1981 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 2, 1981
- Review
- 39 days
- Class
- Class II
- Product code
- KFF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK812424 CI-Trol Heparin Controls, Low/HighAmerican Dade · 1981
- Descendant · cites it directly · 2 of its ownK042941 Dade Behring Heparin Calibrator and ControlsDade Behring, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK083175 Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and…Siemens Healthcare Diagnostics · 2009
- Descendant · 2 generations on · 0 of its ownK051472 Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin…Hyphen Biomed · 2005 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K042941Dade Behring Heparin Calibrator and ControlsDade Behring, Inc. · 2004 · cites it directly2descendants
- K083175Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom Heparin…Siemens Healthcare Diagnostics · 2009 · 2 generations on0descendants
- K051472Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh CalibratorHyphen Biomed · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K812424 | CI-Trol Heparin Controls, Low/High | American Dade | 1981 | — |
| +1 | K042941 | Dade Behring Heparin Calibrator and Controls | Dade Behring, Inc. | 2004 | — |
| +2 | K083175 | Berichrom Heparin UF Calibrator, Berichrom Heparin UF Control 1, and Berichrom… | Siemens Healthcare Diagnostics | 2009 | — |
| +2 | K051472 | Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh… | Hyphen Biomed | 2005 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KFF? 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 KFF device
- #1 K260214 STA® - Liquid Anti-Xascore 12.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042941 | Dade Behring Heparin Calibrator and Controls | 2004 | 2 |
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?
- Of its descendants, K042941 (Dade Behring, Inc., 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KFF devicesKFF Assay, Heparin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KFF
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KFF
Too few KFF 510(k)s in any year since 2007 to give a median.
Recalls per year · KFF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KFF
7in 2025
MAUDE reports naming product code KFF, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K812424 · printed Nov 4, 2026
Cite this page
510(k) Report. “K812424: CI-Trol Heparin Controls, Low/High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K812424
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026