510(k) · Cleared
ClearedSynthasil Aptt Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Diagnostic Systems, Inc. · GFO Activated Partial Thromboplastin
Cleared on Nov 30, 1995 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Nov 30, 1995
- Review
- 99 days
- Class
- Class II
- Product code
- GFO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK953981 Synthasil Aptt ReagentOrtho Diagnostic Systems, Inc. · 1995
- Descendant · cites it directly · 0 of its ownK060688 Hemosil SynthasilInstrumentation Laboratory CO · 2006 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K060688Hemosil SynthasilInstrumentation Laboratory CO · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953981 | Synthasil Aptt Reagent | Ortho Diagnostic Systems, Inc. | 1995 | — |
| +1 | K060688 | Hemosil Synthasil | Instrumentation Laboratory CO | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 GFO? 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 GFO device
- #1 K253957 HemosIL Silica Clotting Timescore 11.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K060688 | Hemosil Synthasil | 2006 | 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?
- Of its descendants, K060688 (Instrumentation Laboratory CO, 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GFO devicesGFO Activated Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GFO
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GFO
Too few GFO 510(k)s in any year since 2007 to give a median.
Recalls per year · GFO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GFO
14in 2025
MAUDE reports naming product code GFO, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 1 | 14 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K953981 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953981: Synthasil Aptt Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953981
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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