510(k) · Cleared
Recalled · Class II · 2026iQ200 Series
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 Sep 10, 2025 as substantially equivalent to K022774 (Intl. Remote Imaging Systems, 2002) and 2 other predicates after a 26-day review. Its family tree reaches back 6 generations to 1994. It has been recalled 2 times.
- Decided
- Sep 10, 2025
- Review
- 26 days
- Class
- Class II
- Product code
- LKM
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 6 generations to K943592 (1994). 18 ancestors in all, the oldest K914256 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK943592 Chemstrip Mini UA Urine AnalyzerBoehringer Mannheim Corp. · 1994
- 5 generations backK983510 Chemstrip 101 Urine AnalyzerBoehringer Mannheim Corp. · 1998
- 4 generations backK013783 Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002
- 3 generations backK101852 Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · Recalled
- 2 generations backK171083 iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017
- 1 generation backK210127 iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc. · 2021 · Recalled
- This deviceK252580 iQ200 SeriesBeckman Coulter, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943592 | Chemstrip Mini UA Urine Analyzer | Boehringer Mannheim Corp. | 1994 | — |
| −5 | K983510 | Chemstrip 101 Urine Analyzer | Boehringer Mannheim Corp. | 1998 | — |
| −4 | K013783 | Aution Max AX-4280 Urinalysis System | International Remote Imaging Systems | 2002 | — |
| −3 | 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 | — |
| −1 | K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry System | Beckman Coulter, Inc. | 2021 | 6 |
| 0 (this device) | K252580 | iQ200 Series | Beckman Coulter, Inc. | 2025 | — |
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 |
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 K232416 AUTION EYE AI-4510 Urine Particle Analysis…score 7.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 5…cell counter Classification Name : Counter, Urine Particle Regulation Number : 864.5200 Product Code(s) : LKM, KQO III. LEGALLY MARKETED PREDICATE DEVICE Predicate # K022774, K093861, K210127 Predicate Trade Name : iQ200 System Product Code : LKM, KQO IV. DEVICE DESCRIPTION SUMMARY The iQ200 Series A… | 2002 |
| * | K093861 | IQ 20 Series Analyzer, IQ 200 Series System, Nad IQ Lamina CradleSummary page 5…nter Classification Name : Counter, Urine Particle Regulation Number : 864.5200 Product Code(s) : LKM, KQO III. LEGALLY MARKETED PREDICATE DEVICE Predicate # K022774, K093861, K210127 Predicate Trade Name : iQ200 System Product Code : LKM, KQO IV. DEVICE DESCRIPTION SUMMARY The iQ200 Series Automated… | 2010 |
| * | K210127 | iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemSummary page 5…sification Name : Counter, Urine Particle Regulation Number : 864.5200 Product Code(s) : LKM, KQO III. LEGALLY MARKETED PREDICATE DEVICE Predicate # K022774, K093861, K210127 Predicate Trade Name : iQ200 System Product Code : LKM, KQO IV. DEVICE DESCRIPTION SUMMARY The iQ200 Series Automated Urine Mic… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 18 ancestors have a recall of any class.
- 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. 2025, 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?
The iQ200 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 iQ200 Analyzer can be used as a stand-alone unit, or the results from the iQ200 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252580: iQ200 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252580
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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