510(k) · Cleared
ClearedIL Test (TM) PT-Fibrinogen HS Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GJS Test, Time, Prothrombin
Cleared on Oct 4, 1993 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 4, 1993
- Review
- 94 days
- Class
- Class II
- Product code
- GJS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK933252 IL Test (TM) PT-Fibrinogen HS PlusInstrumentation Laboratory CO · 1993
- Descendant · cites it directly · 1 of its ownK060931 Hemosil PT-Fibrinogen HS PlusInstrumentation Laboratory CO · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK981479 IL Test PT-Fibrinogen RecombinantInstrumentation Laboratory CO · 1998
- Descendant · 2 generations on · 0 of its ownK183390 QNext and DG-PTDiagnostic Grifols, S.A. · 2019
- Descendant · 2 generations on · 0 of its ownK020840 Vital Scientific PT with CalciumVital Scientific N.V. · 2002
Most influential descendants
Showing 4 of 4 · See all- K060931Hemosil PT-Fibrinogen HS PlusInstrumentation Laboratory CO · 2006 · cites it directly1descendant
- K981479IL Test PT-Fibrinogen RecombinantInstrumentation Laboratory CO · 1998 · cites it directly1descendant
- K183390QNext and DG-PTDiagnostic Grifols, S.A. · 2019 · 2 generations on0descendants
- K020840Vital Scientific PT with CalciumVital Scientific N.V. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933252 | IL Test (TM) PT-Fibrinogen HS Plus | Instrumentation Laboratory CO | 1993 | — |
| +1 | K060931 | Hemosil PT-Fibrinogen HS Plus | Instrumentation Laboratory CO | 2006 | 1 |
| +1 | K981479 | IL Test PT-Fibrinogen Recombinant | Instrumentation Laboratory CO | 1998 | — |
| +2 | K183390 | QNext and DG-PT | Diagnostic Grifols, S.A. | 2019 | — |
| +2 | K020840 | Vital Scientific PT with Calcium | Vital Scientific N.V. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2019 | 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 GJS? 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 GJS device
- #1 K243543 microINR Systemscore 13.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K060931 (Instrumentation Laboratory CO, 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GJS devicesGJS Test, Time, Prothrombin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GJS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GJS
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GJS
1in 2022
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GJS
105in 2025
MAUDE reports naming product code GJS, 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 | 4 | 77 | 5 | 439 |
| 2008 | 1 | — | 3 | 420 |
| 2009 | 0 | — | 4 | 876 |
| 2010 | 4 | 168 | 2 | 2,177 |
| 2011 | 0 | — | 1 | 2,965 |
| 2012 | 1 | — | 1 | 2,198 |
| 2013 | 1 | — | 1 | 2,584 |
| 2014 | 1 | — | 4 (3) | 2,397 |
| 2015 | 0 | — | 0 | 1,260 |
| 2016 | 1 | — | 0 | 864 |
| 2017 | 1 | — | 5 | 532 |
| 2018 | 2 | — | 3 (2) | 1,958 |
| 2019 | 2 | — | 0 | 2,385 |
| 2020 | 1 | — | 2 | 1,390 |
| 2021 | 0 | — | 1 | 1,359 |
| 2022 | 3 | 399 | 1 | 1,210 |
| 2023 | 2 | — | 0 | 809 |
| 2024 | 1 | — | 0 | 177 |
| 2025 | 3 | 60 | 0 | 105 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K933252 · printed Nov 5, 2026
Cite this page
510(k) Report. “K933252: IL Test (TM) PT-Fibrinogen HS Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K933252
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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