510(k) · Cleared
ClearedCoamate (R) Antithrombin Chromogenic Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kabi Pharmacia, Inc. · JBQ Antithrombin Iii Quantitation
Cleared on Jan 3, 1992 after a 52-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.
- Decided
- Jan 3, 1992
- Review
- 52 days
- Class
- Class II
- Product code
- JBQ
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK915083 Coamate (R) Antithrombin Chromogenic AssayKabi Pharmacia, Inc. · 1992
- Descendant · cites it directly · 9 of its ownK980499 IL Test AntithrombinInstrumentation Laboratory CO · 1998
- Descendant · 2 generations on · 4 of its ownK994238 IL Test Liquid AntithrombinInstrumentation Laboratory CO · 2000
- Descendant · 2 generations on · 2 of its ownK033775 Hemosil Liquid Antithrombin XLInstrumentation Laboratory CO · 2004
- Descendant · 2 generations on · 2 of its ownK022195 Coamatic at-400Instrumentation Laboratory CO · 2002
- Descendant · 3 generations on · 1 of its ownK062431 Hemosil Liquid AntithrombinInstrumentation Laboratory CO · 2006
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K980499IL Test AntithrombinInstrumentation Laboratory CO · 1998 · cites it directly9descendants
- K994238IL Test Liquid AntithrombinInstrumentation Laboratory CO · 2000 · 2 generations on4descendants
- K033775Hemosil Liquid Antithrombin XLInstrumentation Laboratory CO · 2004 · 2 generations on2descendants
- K022195Coamatic at-400Instrumentation Laboratory CO · 2002 · 2 generations on2descendants
- K062431Hemosil Liquid AntithrombinInstrumentation Laboratory CO · 2006 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915083 | Coamate (R) Antithrombin Chromogenic Assay | Kabi Pharmacia, Inc. | 1992 | — |
| +1 | K980499 | IL Test Antithrombin | Instrumentation Laboratory CO | 1998 | — |
| +2 | K994238 | IL Test Liquid Antithrombin | Instrumentation Laboratory CO | 2000 | — |
| +2 | K033775 | Hemosil Liquid Antithrombin XL | Instrumentation Laboratory CO | 2004 | — |
| +2 | K022195 | Coamatic at-400 | Instrumentation Laboratory CO | 2002 | — |
| +3 | K062431 | Hemosil Liquid Antithrombin | Instrumentation Laboratory CO | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2018 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (11)
See all 112 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, K980499 (Instrumentation Laboratory CO, 1998) has gone furthest, with 9 descendants of its own.
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 | — |
https://510kreport.com/device/K915083 · printed Nov 3, 2026
Cite this page
510(k) Report. “K915083: Coamate (R) Antithrombin Chromogenic Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K915083
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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