510(k) · Cleared
ClearedCoag-a-Mate MTX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organon Teknika Corp. · GKP Instrument, Coagulation, Automated
Cleared on Jan 22, 1997 as substantially equivalent to K924453 (Organon Teknika Corp., 1992) and 1 other predicate after a 184-day review. Its family tree reaches back 1 generation to 1982. 2 later devices descend from it.
- Decided
- Jan 22, 1997
- Review
- 184 days
- Class
- Class II
- Product code
- GKP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K813564 (1982). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK813564 Coag-a-Mate X2General Diagnostics · 1982
- This deviceK962857 Coag-a-Mate MTXOrganon Teknika Corp. · 1997
- Descendant · cites it directly · 0 of its ownK051030 Coag-a-Mate MTX IiibioMerieux, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK033137 Potens +Wada, Inc. · 2003
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 |
|---|---|---|---|---|---|
| −1 | K813564 | Coag-a-Mate X2 | General Diagnostics | 1982 | — |
| 0 (this device) | K962857 | Coag-a-Mate MTX | Organon Teknika Corp. | 1997 | — |
| +1 | K051030 | Coag-a-Mate MTX Iii | bioMerieux, Inc. | 2005 | — |
| +1 | K033137 | Potens + | Wada, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 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 GKP? 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 GKP device
- #1 K242127 ACL TOP Family 50 Series (ACL TOP 750; ACL TOP…score 9.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K924453 | Multi-Channel Discrete Analyzer (Mda-180)Summary page 1…on Studies (aX3) An identification of the legally marketed device to which the submitter claims substantial equivalence. Device Equivalent to: Organon Teknika MDA-180 (K924453) - Organon Teknika Coag-A-Mate X2 (K813564) (2)(4) A description of the device Device description: Automated system for in vitr… | 1992 |
| * | K813564 | Coag-a-Mate X2Summary page 1…legally marketed device to which the submitter claims substantial equivalence. Device Equivalent to: Organon Teknika MDA-180 (K924453) - Organon Teknika Coag-A-Mate X2 (K813564) (2)(4) A description of the device Device description: Automated system for in vitro coagulation studies, clot based and chrom… | 1982 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GKP devicesGKP Instrument, Coagulation, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GKP
Too few GKP 510(k)s in any year since 2007 to give a median.
Recalls per year · GKP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKP
5in 2024
MAUDE reports naming product code GKP, 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 | — | 3 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 190 |
| 2010 | 0 | — | 4 | 74 |
| 2011 | 0 | — | 0 | 45 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 24 |
| 2016 | 1 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 38 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 1 | 4 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Coag-A-Mate MTX is a multipurpose system for use in performing in-vitro coagulation studies, clot based and chromogenic.
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/K962857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962857: Coag-a-Mate MTX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962857
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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