Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OBH · Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
121 daysmedian FDA review time
770 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | ImpediMed Limited | 2026-01-28 | 121 | 0 |
| K230530 | SOZO Pro | ImpediMed Limited | 2023-05-04 | 66 | 0 |
| K220557 | MoistureMeterD Compact, LymphScanner | Delfin Technologies, Ltd. | 2022-05-27 | 88 | 0 |
| K180126 | SOZO | ImpediMed Limited | 2018-04-16 | 90 | 1 |
| K172122 | SOZO | ImpediMed Limited | 2017-08-11 | 29 | 0 |
| K143310 | MoisturemeterD | Delfin Technologies, Ltd. | 2015-11-19 | 366 | 0 |
| K130338 | IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS | ImpediMed Limited | 2013-05-31 | 109 | 0 |
| K100811 | IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 | ImpediMed Limited | 2011-11-04 | 592 | 0 |
| K080825 | IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 | Impedimed Pty , Ltd. | 2008-10-03 | 193 | 0 |
| K050415 | IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS | Impedimed Pty , Ltd. | 2007-03-30 | 770 | 0 |
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