510(k) · Cleared
Recalled · Class II · 2025Hemosil Synthasil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GFO Activated Partial Thromboplastin
Cleared on Apr 13, 2006 as substantially equivalent to K953981 (Ortho Diagnostic Systems, Inc., 1995) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 2000. It has been recalled once.
- Decided
- Apr 13, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- GFO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002400 (2000). 3 ancestors in all, the oldest K953981 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002400 | Modification of Acl Advance | Instrumentation Laboratory CO | 2000 | 2 |
| −1 | K033414 | Acl Top Model, Top | Instrumentation Laboratory CO | 2004 | 1 |
| 0 (this device) | K060688 | Hemosil Synthasil | Instrumentation Laboratory CO | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 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 11.6 · 4 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 |
|---|---|---|---|
| * | K953981 | Synthasil Aptt ReagentSummary page 1…Regulation No.: 864.7925 Classification Name: Partial Thromboplastin Time Tests Product Code: GFO Panel: Hematology Predicate Device: K953981 HemoslL SynthASil Device Description: HemoslL SynthASil is a high quality synthetic phospholipid reagent for the… | 1995 |
| * | K033414 | Acl Top Model, TopSummary page 1…eter settings on the ACL Futura (K951891) and ACL Advance (K002400) is substantially equivalent to the performance of the current legally marketed device on the ACL TOP (K033414). Section 3 Special 510(k): HemosIL SynthASil Parameter Modification Page I of 2… | 2004 |
| † | K951891 | Acl Futura Coagulation System | 1995 |
| † | K002400 | Modification of Acl Advance | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2025 | Class II | Z-1095-2026 | Under Investigation by firm | Potential for microbial contamination. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
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 | — |
What is it indicated for?
HemosiL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060688 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060688: Hemosil Synthasil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060688
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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