510(k) · Cleared
Recalled · Class II · 2026iQ200 System, iChemVELOCITY Automated Urine Chemistry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · LKM Counter, Urine Particle
Cleared on Jul 2, 2021 as substantially equivalent to K022774 (Intl. Remote Imaging Systems, 2002) and 5 other predicates after a 164-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Jul 2, 2021
- Review
- 164 days
- Class
- Class II
- Product code
- LKM
- Recalls
- 6
- Predicates
- 6
Its longest line of descent runs back 5 generations to K943592 (1994). 17 ancestors in all, the oldest K914256 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK943592 Chemstrip Mini UA Urine AnalyzerBoehringer Mannheim Corp. · 1994
- 4 generations backK983510 Chemstrip 101 Urine AnalyzerBoehringer Mannheim Corp. · 1998
- 3 generations backK013783 Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002
- 2 generations backK101852 Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · Recalled
- 1 generation backK171083 iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017
- This deviceK210127 iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK252580 iQ200 SeriesBeckman Coulter, Inc. · 2025 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K252580iQ200 SeriesBeckman Coulter, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943592 | Chemstrip Mini UA Urine Analyzer | Boehringer Mannheim Corp. | 1994 | — |
| −4 | K983510 | Chemstrip 101 Urine Analyzer | Boehringer Mannheim Corp. | 1998 | — |
| −3 | K013783 | Aution Max AX-4280 Urinalysis System | International Remote Imaging Systems | 2002 | — |
| −2 | K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit | Iris International Inc., A Division of Iris Iris I | 2011 | 11 |
| −1 | K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | 2017 | — |
| 0 (this device) | K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | 2021 | — |
| +1 | K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LKM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LKM device
- #1 K252580 iQ200 Seriesscore 9.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K022774 | IQ 200 SystemSummary page 4…ared Classification 21 CFR Product Number Code iQ200 System K022774 Oct. 21, 2002 Class II 864.5200 LKM Class I 8… | 2002 |
| * | K050235 | IQ 200 Urine Analyzer Body Fluids ModuleSummary page 4…Oct. 21, 2002 Class II 864.5200 LKM Class I 862.2900 KQO iQ200 Urine Analyzer K050235 Mar. 23, 2005 Class II 864.5200 GKL Body Fluids Module iQ200 System with K093861 Feb. 05, 2010… | 2005 |
| * | K093861 | IQ 20 Series Analyzer, IQ 200 Series System, Nad IQ Lamina CradleSummary page 4…I 862.2900 KQO iQ200 Urine Analyzer K050235 Mar. 23, 2005 Class II 864.5200 GKL Body Fluids Module iQ200 System with K093861 Feb. 05, 2010 Class II 864.5200 LKM Lamina Cradle Class I 8… | 2010 |
| * | K091539 | IQ 200 Urine Analizer Body Fluids ModuleSummary page 4…Feb. 05, 2010 Class II 864.5200 LKM Lamina Cradle Class I 862.2900 KQO iQ200 Urine Analyzer K091539 Aug. 31, 2010 Class II 864.5200 GKL Body Fluids Module (The addition of Synovial Fluid) iChemVELOCIT… | 2010 |
| * | K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitSummary page 4…00 Urine Analyzer K091539 Aug. 31, 2010 Class II 864.5200 GKL Body Fluids Module (The addition of Synovial Fluid) iChemVELOCITY K101852 Mar. 23, 2011 Class I 862.2900 KQO Automated Urine Chemistry Special 510k Submission for the iQ200 and… | 2011 |
| * | K171083 | iChemVELOCITY Automated Urine Chemistry SystemSummary page 5…5.0 Section 5:510(k) Summary Page 1 of 13 iChemVELOCITY K171083 May 12, 2017 Class II 862.1340 JIL Automated Urine Class I… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252580 | iQ200 Series | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2026 | Class II | Z-0161-2027 | Component design/selection | The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance… |
| Aug 12, 2026 | Class II | Z-0160-2027 | Component design/selection | The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance… |
| Apr 5, 2023 | Class II | Z-1597-2023 | Under Investigation by firm | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated. |
| Apr 5, 2023 | Class II | Z-1599-2023 | Under Investigation by firm | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated. |
| Apr 5, 2023 | Class II | Z-1596-2023 | Under Investigation by firm | Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated. |
| Apr 5, 2023 | Class II | Z-1598-2023 | Under Investigation by firm | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K252580 (Beckman Coulter, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K022774.
How does its category compare?
All LKM devicesLKM Counter, Urine Particle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LKM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKM
Too few LKM 510(k)s in any year since 2007 to give a median.
Recalls per year · LKM
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKM
1in 2021
MAUDE reports naming product code LKM, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 4 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1Q200 System: The 1Q200 automated urine microscopy system is an in vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the Q200 analyzer can be used as a stand-alone unit, or the results from the Q200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed…
Read the full statement (281 words)
1Q200 System:
The 1Q200 automated urine microscopy system is an in vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the Q200 analyzer can be used as a stand-alone unit, or the results from the Q200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.
iChemVELOCITY Automated Urine Chemistry System:
The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with Q200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrite, color and clarity.
iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostics use only.
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/K210127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210127: iQ200 System, iChemVELOCITY Automated Urine Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210127
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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