510(k) · Cleared
Cleared2700 Sample Manager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waters Corporation · JQW Station, Pipetting And Diluting, For Clinical Use
Cleared on Feb 12, 1998 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 12, 1998
- Review
- 23 days
- Class
- Class I
- Product code
- JQW
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
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 | — |
What is it indicated for?
The Waters 2700 Sample Manager is designed for use in a clinical laboratory to manage sample injection for high throughput LC and LCMS applications. The 2700 Sample Manager automates sample aspiration and injection from microtiter plates, test tubes, Eppendorf tubes, or conventional autosampler vials.
This product is intended for In Vitro Diagnostic Use.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980180: 2700 Sample Manager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980180
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026