510(k) · Cleared
Recalled · Class II · 2023Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls
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 Jun 2, 2009 as substantially equivalent to K980242 (Instrumentation Laboratory CO, 1998) and 2 other predicates after a 125-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 2, 2009
- Review
- 125 days
- Class
- Class II
- Product code
- KFF
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 2 generations to K935212 (1994). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK935212 IL Test Heparin (XA), PN 84699-15Instrumentation Laboratory CO · 1994
- 1 generation backK980242 IL Test HeparinInstrumentation Laboratory CO · 1998 · Recalled
- This deviceK090209 Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin…Instrumentation Laboratory CO · 2009
- Descendant · cites it directly · 2 of its ownK213464 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK223187 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023
- Descendant · 2 generations on · 0 of its ownK240315 INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05)…Siemens Healthcare Diagnostics Products GmbH · 2024
- Descendant · cites it directly · 0 of its ownK163498 VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2017
Most influential descendants
Showing 4 of 4 · See all- K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022 · cites it directly2descendants
- K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023 · 2 generations on1descendant
- K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…Siemens Healthcare Diagnostics Products GmbH · 2024 · 2 generations on0descendants
- K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935212 | IL Test Heparin (XA), PN 84699-15 | Instrumentation Laboratory CO | 1994 | — |
| −1 | K980242 | IL Test Heparin | Instrumentation Laboratory CO | 1998 | 1 |
| 0 (this device) | K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls | Instrumentation Laboratory CO | 2009 | — |
| +1 | K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2022 | 2 |
| +2 | K223187 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2023 | — |
| +2 | K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE… | Siemens Healthcare Diagnostics Products GmbH | 2024 | — |
| +1 | K163498 | VALIDATE Heparin Calibration Verification/Linearity Test Kit | Maine Standards Company, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 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
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K980242 | IL Test HeparinSummary page 1…ass II 'Product Code: JIS 21 CFR 862.1150 Controls: Class II Product Code: GGN 21 CFR 864.5425 Predicate Devices: K980242 HemoslL Heparin K030964 Calibration Plasma LMW Heparin K030965 Control Plas… | 1998 |
| * | K030964 | Calibration Plasma LMW HeparinSummary page 1…21 CFR 862.1150 Controls: Class II Product Code: GGN 21 CFR 864.5425 Predicate Devices: K980242 HemoslL Heparin K030964 Calibration Plasma LMW Heparin K030965 Control Plasma LMW Heparin Device Intended Uses: - H… | 2003 |
| * | K030965 | Control Plasma LMW HeparinSummary page 1…Product Code: GGN 21 CFR 864.5425 Predicate Devices: K980242 HemoslL Heparin K030964 Calibration Plasma LMW Heparin K030965 Control Plasma LMW Heparin Device Intended Uses: - HemosIL Liquid Heparin: Automated chromogenic assay for the… | 2003 |
What descends from it? (4)
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, 2023 | Class II | Z-1304-2023 | Device Design | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments |
| Feb 3, 2023 | Class II | Z-1306-2023 | Device Design | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments |
| Feb 3, 2023 | Class II | Z-1307-2023 | Device Design | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments |
| Feb 3, 2023 | Class II | Z-1305-2023 | Device Design | Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments |
| Aug 25, 2021 | Class II | Z-0149-2022 | Device Design | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 11.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K213464 (Instrumentation Laboratory CO, 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K980242.
How does its category compare?
All KFF devicesKFF Assay, Heparin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems). HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE…
Read the full statement (141 words)
HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liquid Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liquid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090209: Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090209
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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