510(k) · Cleared
ClearedCoamatic Heparin
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 Nov 3, 1998 as substantially equivalent to K980242 (Instrumentation Laboratory CO, 1998) after a 53-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Nov 3, 1998
- Review
- 53 days
- Class
- Class II
- Product code
- KFF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K935212 (1994). 1 later device descends from it, 1 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 deviceK983178 Coamatic HeparinInstrumentation Laboratory CO · 1998
- Descendant · cites it directly · 0 of its ownK162540 INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator…Siemens Healthcare Diagnostics Prodcts GmbH · 2017
Most influential descendants
Showing 1 of 1 · See all- K162540INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator, INNOVANCE (r) Heparin…Siemens Healthcare Diagnostics Prodcts GmbH · 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) | K983178 | Coamatic Heparin | Instrumentation Laboratory CO | 1998 | — |
| +1 | K162540 | INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator, INNOVANCE… | Siemens Healthcare Diagnostics Prodcts GmbH | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (1)
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…r 10, 1998 Name of the device: Coamatic® Heparin Classification name(s): 864.7525 Heparin Assay Class 11 81KFF Assay, Heparin Identification of predicate device(s): K980242 IL Test™ Heparin Description of the device/intended use(s): Coamatic® Heparin is an in vitro diagnostic test for the quantitat… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162540 | INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator, INNOVANCE (r) Heparin… | 2017 | 0 |
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 4 years and passes through 1 company; a new generation was cleared every 4.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K162540 (Siemens Healthcare Diagnostics Prodcts GmbH, 2017) has gone furthest, with 0 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.
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?
Coamatic® Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma using automated and microplate methods. The amount of UFH or LMWH is determined from the anti-FXa activity expressed by the [AT*Heparin] complex formed in plasma.
Heparin is the most frequently used antithrombotic drug. The biological activity of this sulphated glycosaminoglycan resides in its ability to accelerate (up to 2000-fold) the inhibitory effect of antithrombin on coagulation proteases.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983178 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983178: Coamatic Heparin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983178
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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