Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

ImpediMed Limited — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

121 daysmedian FDA review time
298 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited2026-01-281210
K232089SOZO ProImpediMed Limited2023-10-17960
K230530SOZO ProImpediMed Limited2023-05-04660
K230531SOZO ProImpediMed Limited2023-05-04660
K203473SOZOImpediMed Limited2021-04-191450
K193410SOZO Body Fluid AnalyzerImpediMed Limited2020-10-022980
K190529SOZOImpediMed Limited2019-11-252660
K180126SOZOImpediMed Limited2018-04-16901
K172507SOZOImpediMed Limited2017-12-221260
K172122SOZOImpediMed Limited2017-08-11290
K130338IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSISImpediMed Limited2013-05-311090
K100811IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400ImpediMed Limited2011-11-045920

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