510(k) · Cleared
ClearedIL Test Fibrinogen-C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · KQJ System, Fibrinogen Determination
Cleared on Aug 13, 1993 after a 128-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Aug 13, 1993
- Review
- 128 days
- Class
- Class II
- Product code
- KQJ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK931721 IL Test Fibrinogen-CInstrumentation Laboratory CO · 1993
- Descendant · cites it directly · 1 of its ownK073367 Hemosil Fibrinogen-CInstrumentation Laboratory CO · 2007
- Descendant · 2 generations on · 0 of its ownK251968 HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co. · 2025
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 |
|---|---|---|---|---|---|
| 0 (this device) | K931721 | IL Test Fibrinogen-C | Instrumentation Laboratory CO | 1993 | — |
| +1 | K073367 | Hemosil Fibrinogen-C | Instrumentation Laboratory CO | 2007 | — |
| +2 | K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2025 | 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 KQJ? 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 KQJ device
- #1 K251968 HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLscore 10.0 · 2 generations · no Class I recall
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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073367 | Hemosil Fibrinogen-C | 2007 | 1 |
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, K073367 (Instrumentation Laboratory CO, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KQJ devicesKQJ System, Fibrinogen Determination: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K931721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931721: IL Test Fibrinogen-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931721
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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