510(k) · Decided
DecidedHeparin Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Bioproducts Co. · KFF Assay, Heparin
Cleared on Sep 26, 1995 after a 432-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
- Sep 26, 1995
- Review
- 432 days
- Class
- Class II
- Product code
- KFF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK943520 Heparin Control KitAmerican Bioproducts Co. · 1995
- Descendant · cites it directly · 1 of its ownK111822 Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh…Diagnostica Stago, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK260214 STA® - Liquid Anti-XaDiagnostica Stago, Inc. · 2026
- 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 3 of 3 · See all- K111822Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWHDiagnostica Stago, Inc. · 2011 · cites it directly1descendant
- K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc. · 2026 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K943520 | Heparin Control Kit | American Bioproducts Co. | 1995 | — |
| +1 | K111822 | Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality… | Diagnostica Stago, Inc. | 2011 | 3 |
| +2 | K260214 | STA® - Liquid Anti-Xa | Diagnostica Stago, Inc. | 2026 | — |
| +1 | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2026 | 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)
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?
- Of its descendants, K111822 (Diagnostica Stago, Inc., 2011) has gone furthest, with 1 descendant 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/K943520 · printed Nov 5, 2026
Cite this page
510(k) Report. “K943520: Heparin Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943520
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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