510(k) · Cleared
Cleared900UDX Urine Pathology System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intl. Remote Imaging Systems · KQO Automated Urinalysis System
Cleared on Mar 22, 1996 after a 78-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 22, 1996
- Review
- 78 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK960054 900UDX Urine Pathology SystemIntl. Remote Imaging Systems · 1996
- Descendant · cites it directly · 3 of its ownK101852 Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK171083 iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK210127 iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK252580 iQ200 SeriesBeckman Coulter, Inc. · 2025 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · cites it directly3descendants
- K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017 · 2 generations on2descendants
- K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. · 2021 · 2 generations on1descendant
- K252580iQ200 SeriesBeckman Coulter, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960054 | 900UDX Urine Pathology System | Intl. Remote Imaging Systems | 1996 | — |
| +1 | K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit | Iris International Inc., A Division of Iris Iris I | 2011 | 11 |
| +2 | K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | 2017 | — |
| +2 | K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | 2021 | 6 |
| +3 | K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
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 KQO? 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? (2)
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 |
|---|---|---|---|
| * | — | The Yellow IRIS® Urinalysis Workstation with CHEMSTRIP® Reader Named without a submission number | |
| * | — | IRIS Flow Microscope Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit | 2011 | 3 |
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, K101852 (Iris International Inc., A Division of Iris Iris I, 2011) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KQO devicesKQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KQO
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KQO
Too few KQO 510(k)s in any year since 2007 to give a median.
Recalls per year · KQO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KQO
12in 2025
MAUDE reports naming product code KQO, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 2 | — | 7 | 3 |
| 2011 | 2 | — | 2 | 8 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 1 | — | 1 | 92 |
| 2014 | 1 | — | 0 | 106 |
| 2015 | 2 | — | 0 | 238 |
| 2016 | 0 | — | 1 | 373 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 2 | 64 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 1 | 13 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The 900UDx Urine Pathology System performs routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination.
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/K960054 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960054: 900UDX Urine Pathology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960054
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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