510(k) · Cleared
ClearedImpact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Matrix Technologies Corp. · JQW Station, Pipetting And Diluting, For Clinical Use
Cleared on May 3, 1994 after a 97-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 18 later devices descend from it.
- Decided
- May 3, 1994
- Review
- 97 days
- Class
- Class I
- Product code
- JQW
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 2 citing it directly.
- This deviceK940390 ImpactMatrix Technologies Corp. · 1994
- Descendant · cites it directly · 15 of its ownK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 14 of its ownK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 10 of its ownK033734 Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · Recalled
- Descendant · 4 generations on · 4 of its ownK051713 Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005
- Descendant · 4 generations on · 3 of its ownK070597 Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and…Nanosphere, Inc. · 2007
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K964506Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · cites it directly15descendants
- K012966Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · 2 generations on14descendants
- K033734Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · 3 generations on10descendants
- K051713Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005 · 4 generations on4descendants
- K070597Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNanosphere, Inc. · 2007 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940390 | Impact | Matrix Technologies Corp. | 1994 | — |
| +1 | K964506 | Roche Cobas Amplicor Analyzer | Roche Molecular Systems, Inc. | 1997 | 1 |
| +2 | K012966 | Roche Cobas Taqman Analyzer | Roche Molecular Systems, Inc. | 2002 | 3 |
| +3 | K033734 | Lightcycler Instrument Version 1.2 | Roche Diagnostics Corp. | 2003 | 1 |
| +4 | K051713 | Jbaids Anthrac Detection System | Idaho Technology, Inc. | 2005 | — |
| +4 | K070597 | Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic… | Nanosphere, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 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 JQW? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (18)
See all 182 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, K964506 (Roche Molecular Systems, Inc., 1997) has gone furthest, with 15 descendants of its own.
How does its category compare?
All JQW devicesJQW Station, Pipetting And Diluting, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JQW
FDA has decided no JQW device since 2007.
Median 510(k) review, days · JQW
Too few JQW 510(k)s in any year since 2007 to give a median.
Recalls per year · JQW
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JQW
11in 2025
MAUDE reports naming product code JQW, 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 | — | 2 | 41 |
| 2008 | 0 | — | 2 | 20 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 3 | 4 |
| 2011 | 0 | — | 2 | 32 |
| 2012 | 0 | — | 2 | 17 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 1 | 11 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 2 | 5 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 27 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K940390 · printed Nov 4, 2026
Cite this page
510(k) Report. “K940390: Impact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940390
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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