510(k) · Cleared
ClearedThrombonostika F1.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organon Teknika Corp. · MIF Prothrombin Fragment 1.2
Cleared on Mar 18, 1997 as substantially equivalent to K911434 (Organon Teknika Corp., 1991) after a 99-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Mar 18, 1997
- Review
- 99 days
- Class
- Class II
- Product code
- MIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911434 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK911434 Thrombonostika F1.2Organon Teknika Corp. · 1991
- This deviceK964934 Thrombonostika F1.2Organon Teknika Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911434 | Thrombonostika F1.2 | Organon Teknika Corp. | 1991 | — |
| 0 (this device) | K964934 | Thrombonostika F1.2 | Organon Teknika Corp. | 1997 | — |
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 MIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K911434 | Thrombonostika F1.2Summary page 2…t 1.2 (F1.2) (a) 3) An identification of the legally marketed device to which the submitter claims substantial equivalence. Device Equivalent to: Thrombonostika F1.2 (K911434) (a) (4) A description of the device(System) Thrombonostika F1.2 is a two-stage enzymed-linked immunosorbent assay for the prot… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All MIF devicesMIF Prothrombin Fragment 1.2: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MIF
FDA has decided no MIF device since 2007.
Median 510(k) review, days · MIF
Too few MIF 510(k)s in any year since 2007 to give a median.
Recalls per year · MIF
No recall names MIF since 2007.
Adverse event reports per year · MIF
No MAUDE report names MIF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 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 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Thrombonostika F1.2 is an enzymed-linked immunosorbent assay for the quantitative determination of prothrombin activation fragment 1.2 (F1.2) in human plasma. It is indicated as an aid to both assess the risk of thrombosis and monitor the efficacy of anticoagulant therapy.
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/K964934 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964934: Thrombonostika F1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964934
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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