510(k) · Cleared
ClearedLucor Confirmatory Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gradipore, Ltd. · GIR Reagent, Russel Viper Venom
Cleared on Apr 6, 1993 after a 334-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Apr 6, 1993
- Review
- 334 days
- Class
- Class I
- Product code
- GIR
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK922156 Lucor Confirmatory ReagentGradipore, Ltd. · 1993
- Descendant · cites it directly · 7 of its ownK990302 IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm…Instrumentation Laboratory CO · 1999
- Descendant · 2 generations on · 2 of its ownK050221 Hemosil Silica Clotting TimeInstrumentation Laboratory CO · 2005
- Descendant · 3 generations on · 1 of its ownK160445 HemosIL Silica Clotting TimeInstrumentation Laboratory CO · 2016
- Descendant · 2 generations on · 1 of its ownK110031 Hemosil Drvvt Screen & Hemosil Drvvt ConfirmInstrumentation Laboratory CO · 2011
- Descendant · 2 generations on · 1 of its ownK061805 Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmDiagnostica Stago, Inc. · 2006
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K990302IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims Addad to…Instrumentation Laboratory CO · 1999 · cites it directly7descendants
- K050221Hemosil Silica Clotting TimeInstrumentation Laboratory CO · 2005 · 2 generations on2descendants
- K160445HemosIL Silica Clotting TimeInstrumentation Laboratory CO · 2016 · 3 generations on1descendant
- K110031Hemosil Drvvt Screen & Hemosil Drvvt ConfirmInstrumentation Laboratory CO · 2011 · 2 generations on1descendant
- K061805Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmDiagnostica Stago, Inc. · 2006 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922156 | Lucor Confirmatory Reagent | Gradipore, Ltd. | 1993 | — |
| +1 | K990302 | IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims… | Instrumentation Laboratory CO | 1999 | — |
| +2 | K050221 | Hemosil Silica Clotting Time | Instrumentation Laboratory CO | 2005 | — |
| +3 | K160445 | HemosIL Silica Clotting Time | Instrumentation Laboratory CO | 2016 | — |
| +2 | K110031 | Hemosil Drvvt Screen & Hemosil Drvvt Confirm | Instrumentation Laboratory CO | 2011 | — |
| +2 | K061805 | Sta - Staclot DRVV Screen; Sta - Staclot DRVV Confirm | Diagnostica Stago, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2026 | 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 GIR? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990302 | IL Test Lac Screen (Claims Added to Acl Futura), IL Test Lac Confirm (Claims Addad to… | 1999 | 7 |
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, K990302 (Instrumentation Laboratory CO, 1999) has gone furthest, with 7 descendants of its own.
How does its category compare?
All GIR devicesGIR Reagent, Russel Viper Venom: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GIR
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · GIR
Too few GIR 510(k)s in any year since 2007 to give a median.
Recalls per year · GIR
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIR
3in 2018
MAUDE reports naming product code GIR, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K922156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922156: Lucor Confirmatory Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922156
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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