510(k) · Cleared
ClearedHemosil 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 Dec 27, 2007 as substantially equivalent to K931721 (Instrumentation Laboratory CO, 1993) after a 27-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Dec 27, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- KQJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931721 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK931721 IL Test Fibrinogen-CInstrumentation Laboratory CO · 1993
- This deviceK073367 Hemosil Fibrinogen-CInstrumentation Laboratory CO · 2007
- Descendant · cites it directly · 0 of its ownK251968 HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931721 | IL Test Fibrinogen-C | Instrumentation Laboratory CO | 1993 | — |
| 0 (this device) | K073367 | Hemosil Fibrinogen-C | Instrumentation Laboratory CO | 2007 | — |
| +1 | 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 |
|---|---|---|
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K931721 | IL Test Fibrinogen-CSummary page 1…Fibrinogen-C Regulatory Information: KQJ System, Fibrinogen Determination 864.7340 Fibrinogen Determination System Class II Predicate Device: K931721 HemosIL Fibrinogen-C Device Intended Use: HemosIL Fibrinogen-C is intended for the quantitative determination of fibrinogen,… | 1993 |
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 |
|---|---|---|---|
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | 2025 | 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?
- Its one ancestor has no recall.
- Of its descendants, K251968 (Instrumentation Laboratory (IL) Co., 2025) has gone furthest, with 0 descendants 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. 2007, 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?
HemosIL Fibrinogen-C is intended for the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems.
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073367: Hemosil 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/K073367
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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