510(k) · Cleared
ClearedQuatro SP Sample Processing Systems (200-499, Inclusive)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zenyx Scientific, Ltd. · JQW Station, Pipetting And Diluting, For Clinical Use
Cleared on Apr 30, 1998 as substantially equivalent to K800775 (Sorin Biomedica, Fiat, USA, Inc., 1980) after a 238-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Apr 30, 1998
- Review
- 238 days
- Class
- Class I
- Product code
- JQW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K800775 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK800775 Aldoctk-125Sorin Biomedica, Fiat, USA, Inc. · 1980
- This deviceK973335 Quatro SP Sample Processing Systems (200-499, Inclusive)Zenyx Scientific, Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800775 | Aldoctk-125 | Sorin Biomedica, Fiat, USA, Inc. | 1980 | — |
| 0 (this device) | K973335 | Quatro SP Sample Processing Systems (200-499, Inclusive) | Zenyx Scientific, Ltd. | 1998 | — |
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 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? (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 |
|---|---|---|---|
| * | K800775 | Aldoctk-125Summary page 1…es. The Novapath included a microplate reader with computer interface. This sample processing system was cleared for US marketing on March 9, 1990 under reference number K800775. The differences in the Quatro 200D and other SP Series models involve workstation capacity for handling tubes and microplates, p… | 1980 |
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.
What does this lineage say?
- Its one ancestor has no 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 Quatro SP Series Robotic Sample Processing Systems and their accessories are provided as generic liquid handling systems which must be customized and validated for each user environment, according to in vitro diagnostic test instructions and requirements. The customization can be accomplished by users or can be provided, to customer specifications, by Zenyx authorized representatives.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973335 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973335: Quatro SP Sample Processing Systems (200-499, Inclusive).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973335
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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