510(k) · Cleared
Recalled · Class II · 2025HemosIL Liquid Anti-Xa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · KFF Assay, Heparin
Cleared on Oct 4, 2022 as substantially equivalent to K090209 (Instrumentation Laboratory CO, 2009) and 1 other predicate after a 341-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 4, 2022
- Review
- 341 days
- Class
- Class II
- Product code
- KFF
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935212 (1994). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK935212 IL Test Heparin (XA), PN 84699-15Instrumentation Laboratory CO · 1994
- 2 generations backK980242 IL Test HeparinInstrumentation Laboratory CO · 1998 · Recalled
- 1 generation backK090209 Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin…Instrumentation Laboratory CO · 2009 · Recalled
- This deviceK213464 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022
- Descendant · cites it directly · 1 of its ownK223187 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023
- Descendant · cites it directly · 0 of its ownK240315 INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05)…Siemens Healthcare Diagnostics Products GmbH · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935212 | IL Test Heparin (XA), PN 84699-15 | Instrumentation Laboratory CO | 1994 | — |
| −2 | K980242 | IL Test Heparin | Instrumentation Laboratory CO | 1998 | 1 |
| −1 | K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls | Instrumentation Laboratory CO | 2009 | 5 |
| 0 (this device) | K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2022 | — |
| +1 | K223187 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2023 | — |
| +1 | K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE… | Siemens Healthcare Diagnostics Products GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 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
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 |
|---|---|---|---|
| * | K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin ControlsSummary page 4…Date June, 2022 Device Trade Name HemosIL Liquid Anti-Xa Predicate Device HemosIL Liquid Anti-Xa K090209, DEN190032 Regulatory Information Regulation… | 2009 |
| * | DEN190032 | HemosIL Liquid Anti-XaSummary page 4…June, 2022 Device Trade Name HemosIL Liquid Anti-Xa Predicate Device HemosIL Liquid Anti-Xa K090209, DEN190032 Regulatory Information Regulation… | 2020 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2025 | Class II | Z-2323-2025 | Process control | Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and… |
| Dec 18, 2024 | Class II | Z-1020-2025 | Under Investigation by firm | Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 1 company; a new generation was cleared every 11.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K223187 (Instrumentation Laboratory CO, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K090209.
How does its category compare?
All KFF devicesKFF Assay, Heparin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 | — |
What is it indicated for?
HemoslL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used: * When used with HemoslL Heparin Calibrators: Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family and ACL TOP…
Read the full statement (182 words)
HemoslL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:
* When used with HemoslL Heparin Calibrators:
Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family and ACL TOP Family 50 Series.
* When used with HemoslL Apixaban Calibrators:
Quantitative determination of apixaban on the ACL TOP Family and ACL TOP Family 50 Series through measurement of Factor Xa activity, which is inversely proportional to the apixaban level. With HemoslL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information:
- Patients at risk for major bleeding
- Patients experiencing a bleeding episode
The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings.
For use in adult population. For prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213464: HemosIL Liquid Anti-Xa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213464
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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