Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LKM — Predicate Candidate Screening

15 FDA 510(k) clearances under this product code; the 50 most recent screened below.

64 daysmedian FDA review time
266 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252580iQ200 SeriesBeckman Coulter, Inc.2025-09-10260
K232416AUTION EYE AI-4510 Urine Particle Analysis SystemArkray, Inc.2024-05-032660
K210127iQ200 System, iChemVELOCITY Automated Urine Chemistry SystemBeckman Coulter, Inc.2021-07-021644
K200811cobas u 701 microscopy analyzerRoche Diagnostics2020-11-062240
K171883Sysmex UF-5000 Fully Automated Urine Particle AnalyzerSysmex America, Inc.2018-04-233040
K093861IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CIris International, Inc.2010-02-05514
K083002SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZERSysmex America, Inc.2009-02-031180
K080887SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINSysmex America, Inc.2008-05-02321
K070910SYSMEX MODEL UF1000ISysmex America, Inc.2007-05-25530
K053135SYSMEX UF-100I AUTOMATED URINE CELL ANALYZERSysmex America, Inc.2006-01-04570
K022774IQ 200 SYSTEMIntl. Remote Imaging Systems2002-10-21619
K012372SYSMEX UF-50Sysmex Corp.2001-09-28640
K000373939UDX URINE PATHOLOGY SYSTEMIntl. Remote Imaging Systems2000-04-14700
K961054SYSMEX UF-100Sysmex Corp.1996-10-282240
K822823HEMATOLOGY COMPUTER-INTERFACE, VISCOUNTEko Scann AB1982-10-18270

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda