510(k) · Cleared
ClearedIQ 200 Urine Analyzer Body Fluids Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iris International, Inc. · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Mar 23, 2005 as substantially equivalent to K914256 (Intl. Remote Imaging Systems, 1992) and 3 other predicates after a 50-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Mar 23, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- GKL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K914256 (1992). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK914256 Yellow Iris Urinalysis Wrksta W/Iriscope Bdy FluIntl. Remote Imaging Systems · 1992
- This deviceK050235 IQ 200 Urine Analyzer Body Fluids ModuleIris International, Inc. · 2005
- 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 |
|---|---|---|---|---|---|
| −1 | K914256 | Yellow Iris Urinalysis Wrksta W/Iriscope Bdy Flu | Intl. Remote Imaging Systems | 1992 | — |
| 0 (this device) | K050235 | IQ 200 Urine Analyzer Body Fluids Module | Iris International, Inc. | 2005 | — |
| +1 | K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | 2021 | 6 |
| +2 | K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
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? (5)
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 |
|---|---|---|---|
| * | K914256 | Yellow Iris Urinalysis Wrksta W/Iriscope Bdy FluSummary page 2…copy of Pleural Fluid, Peritoneal Fluid and Peritoneal Dialysate in The Yellow IRIS Urinalysis Workstation (K9 14256), Flow Microscopy of Cerebrospinal Fluid and Seminal Fluid in The Yellow IRIS Urinalysis Workstati… | 1992 |
| * | K934539 | The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis CapabilitySummary page 2…14256), Flow Microscopy of Cerebrospinal Fluid and Seminal Fluid in The Yellow IRIS Urinalysis Workstation (K93453 9), Flow Microscopy of Synovial Fluid and Pericardial Fluid in The Yellow IRIS Urinalysis Workstatio… | 1994 |
| * | K954006 | Yellow Iris Urinalysis Workstation W/Iriscope Body Fluid Analysis CapabilitySummary page 2…(K93453 9), Flow Microscopy of Synovial Fluid and Pericardial Fluid in The Yellow IRIS Urinalysis Workstation (K954006), and the Sysmex XE-2 100 Series Hematology Analyzer Body Fluid App… | 1996 |
| * | K040073 | Sysmex Automated Hematology Analyzer, XE-2100 Series (XE-2100, XE-2100L)Summary page 2…rinalysis Workstation (K954006), and the Sysmex XE-2 100 Series Hematology Analyzer Body Fluid Application (K040073), in its principles and technology, its automated functions and the participative involvement of a… | 2004 |
| * | — | Manual body fluid microscopic cell-count examination by a competent observer using a… Named without a submission number |
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?
- None of the 4 ancestors has a recall.
- 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.
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 a competent human observer to examine and count red blood cells and nucleated cells in cerebrospinal fluid and serous fluids. Cerebrospinal fluid analysis is ordered by physicians to diagnose meningitis, intracranial hemorrhage, leukemias, malignancies and central nervous system disorders. Serous fluid analysis is ordered by physicians to diagnose infections…
Read the full statement (153 words)
The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by a competent human observer to examine and count red blood cells and nucleated cells in cerebrospinal fluid and serous fluids.
Cerebrospinal fluid analysis is ordered by physicians to diagnose meningitis, intracranial hemorrhage, leukemias, malignancies and central nervous system disorders. Serous fluid analysis is ordered by physicians to diagnose infections, hemorrhages, malignancies and other disorders. Cell count determination is a part of these analyses.
The information produced by the iQ 200 Urine Analyzer Body Fluids Module concerning the cell concentrations in CSF and serous body fluids is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Cell count findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050235: IQ 200 Urine Analyzer Body Fluids Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050235
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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