510(k) · Cleared
ClearedHemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory (IL) Co. · KQJ System, Fibrinogen Determination
Cleared on Jul 24, 2025 as substantially equivalent to K073367 (Instrumentation Laboratory CO, 2007) after a 28-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jul 24, 2025
- Review
- 28 days
- Class
- Class II
- Product code
- KQJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931721 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 KQJ? 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 |
|---|---|---|---|
| * | K073367 | Hemosil Fibrinogen-CSummary page 4…ibrinogen-C XL 0020003900 Predicate Device HemosIL Fibrinogen-C K073367 and 510(k) Number Assays… | 2007 |
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?
- The line of descent spans 32 years and passes through 2 companies; a new generation was cleared every 17.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All KQJ devicesKQJ System, Fibrinogen Determination: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KQJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KQJ
Too few KQJ 510(k)s in any year since 2007 to give a median.
Recalls per year · KQJ
No recall names KQJ since 2007.
Adverse event reports per year · KQJ
2in 2024
MAUDE reports naming product code KQJ, 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 | — | 0 | 1 |
| 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 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251968: HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251968
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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