510(k) · Cleared
ClearedIQ 200 Urine Analizer Body Fluids Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iris Diagnostics · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Aug 31, 2010 as substantially equivalent to K091313 (Sysmex America, Inc., 2010) after a 462-day review. Its family tree reaches back 3 generations to 2004. 2 later devices descend from it.
- Decided
- Aug 31, 2010
- Review
- 462 days
- Class
- Class II
- Product code
- GKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040073 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK040073 Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100…Sysmex America, Inc. · 2004
- 2 generations backK071967 Sysmex XE-5000Sysmex America, Inc. · 2007 · Recalled
- 1 generation backK091313 Sysmex Model XT-4000ISysmex America, Inc. · 2010
- This deviceK091539 IQ 200 Urine Analizer Body Fluids ModuleIris Diagnostics · 2010
- Descendant · cites it directly · 1 of its ownK210127 iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK252580 iQ200 SeriesBeckman Coulter, Inc. · 2025 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L) | Sysmex America, Inc. | 2004 | — |
| −2 | K071967 | Sysmex XE-5000 | Sysmex America, Inc. | 2007 | 1 |
| −1 | K091313 | Sysmex Model XT-4000I | Sysmex America, Inc. | 2010 | — |
| 0 (this device) | K091539 | IQ 200 Urine Analizer Body Fluids Module | Iris Diagnostics | 2010 | — |
| +1 | K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | 2021 | 6 |
| +2 | K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 GKL? 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 |
|---|---|---|---|
| * | K091313 | Sysmex Model XT-4000I Cleared while this submission was under review Summary page 1…luids Module is substantially equivalent to the Sysmex® XT-4000i, cleared Mar 30, 201 0 under K091 31 3. 4. Device Description: The iQ®0200 Urine Analyzer Body Fluids Module for… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | 2021 | 1 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K210127 (Beckman Coulter, Inc., 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GKL devicesGKL Counter, Cell, Automated (Particle Counter): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GKL
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GKL
Too few GKL 510(k)s in any year since 2007 to give a median.
Recalls per year · GKL
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKL
1in 2025
MAUDE reports naming product code GKL, 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 | — | 1 | 25 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The iQ®200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by an appropriately trained laboratory user to examine and count red blood cells and nucleated cells in cerebrospinal fluid, serous fluids and synovial fluid. This module is a capability added to the iQ®200 Urine Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091539 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091539: IQ 200 Urine Analizer Body Fluids Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091539
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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