# LKM: Counter, Urine Particle

- Device class: 2; regulation: 21 CFR 864.5200; FDA's rule: 510(k) required
- FDA decisions: 15
- 510(k) review time 2021–2025: median 164 days (middle half 95–215)
- Recalls: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2006: 1
- 2007: 1
- 2008: 1
- 2009: 1
- 2010: 1
- 2018: 1
- 2020: 1
- 2021: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K070910: Sysmex Model UF1000I (2007), cited by 4
- K093861: IQ 20 Series Analyzer, IQ 200 Series System, Nad IQ Lamina Cradle (2010), cited by 3
- K022774: IQ 200 System (2002), cited by 3
- K080887: Sysmex UF-1000I, Automated Urine Particle Analyzer with Urinalysis Wam Software (2008), cited by 2
- K210127: iQ200 System, iChemVELOCITY Automated Urine Chemistry System (2021), cited by 1
- K961054: Sysmex UF-100 (1996), cited by 1

Source page: https://510kreport.com/product-code/LKM
Data by year (CSV): https://510kreport.com/product-code/LKM.csv