510(k) · Cleared
ClearedHemosil Liquid Antithrombin XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JBQ Antithrombin Iii Quantitation
Cleared on Jan 2, 2004 as substantially equivalent to K980499 (Instrumentation Laboratory CO, 1998) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.
- Decided
- Jan 2, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- JBQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915083 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK915083 Coamate (R) Antithrombin Chromogenic AssayKabi Pharmacia, Inc. · 1992
- 2 generations backK980499 IL Test AntithrombinInstrumentation Laboratory CO · 1998
- 1 generation backK994238 IL Test Liquid AntithrombinInstrumentation Laboratory CO · 2000
- This deviceK033775 Hemosil Liquid Antithrombin XLInstrumentation Laboratory CO · 2004
- Descendant · cites it directly · 1 of its ownK062431 Hemosil Liquid AntithrombinInstrumentation Laboratory CO · 2006
- Descendant · 2 generations on · 0 of its ownK173202 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator…Sekisui Medical Co., Ltd. · 2018
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 | K915083 | Coamate (R) Antithrombin Chromogenic Assay | Kabi Pharmacia, Inc. | 1992 | — |
| −2 | K980499 | IL Test Antithrombin | Instrumentation Laboratory CO | 1998 | — |
| −1 | K994238 | IL Test Liquid Antithrombin | Instrumentation Laboratory CO | 2000 | — |
| 0 (this device) | K033775 | Hemosil Liquid Antithrombin XL | Instrumentation Laboratory CO | 2004 | — |
| +1 | K062431 | Hemosil Liquid Antithrombin | Instrumentation Laboratory CO | 2006 | — |
| +2 | K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia… | Sekisui Medical Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2018 | 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 JBQ? 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 JBQ device
- #1 K242952 INNOVANCE Antithrombinscore 9.1 · 1 generation · 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 |
|---|---|---|---|
| * | K980499 | IL Test AntithrombinSummary page 1…hrombin XL Classification Name: 864.7060 Antithrombin III Assay Class II 81JBQ Antithrombin HI Quantitation Identification of predicate device: K980499 HemoslL Antithrombin Description of the modified device: HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liq… | 1998 |
| * | K994238 | IL Test Liquid AntithrombinSummary page 1…dicate device: K980499 HemoslL Antithrombin Description of the modified device: HemosIL Liquid Antithrombin XL is a modified version of HemosIL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K00… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062431 | Hemosil Liquid Antithrombin | 2006 | 1 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K062431 (Instrumentation Laboratory CO, 2006) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K980499.
How does its category compare?
All JBQ devicesJBQ Antithrombin Iii Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JBQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JBQ
Too few JBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JBQ
No recall names JBQ since 2007.
Adverse event reports per year · JBQ
1in 2023
MAUDE reports naming product code JBQ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HemosiL Liquid Antithrombin XL is a modified version of HemoslL Liquid Antithrombin (K994238) with optimized reagent volumes for use on specific IL Coagulation Systems, such as the ACL Futura (K951891) and ACL Advance (K002400).
This modification does not alter the fundamental scientific technology of the device or its intended use as an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033775: Hemosil Liquid Antithrombin XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033775
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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