# K252580: iQ200 Series

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Sep 10, 2025 after 26 days
- Product code: LKM (Counter, Urine Particle)
- Device class: 2
- Regulation: 21 CFR 864.5200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K943592 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022774: IQ 200 System, Intl. Remote Imaging Systems (2002) Summary page 5.
- K093861: IQ 20 Series Analyzer, IQ 200 Series System, Nad IQ Lamina Cradle, Iris International, Inc. (2010) Summary page 5.
- K210127: iQ200 System, iChemVELOCITY Automated Urine Chemistry System, Beckman Coulter, Inc. (2021) Summary page 5.

## Recalls of this device
- Aug 12, 2026 · Class II · Z-0161-2027: 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 fr
- Aug 12, 2026 · Class II · Z-0160-2027: 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 fr

## Indications for use
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.

Source page: https://510kreport.com/device/K252580
Methodology: https://510kreport.com/methodology