Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OUJ · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250434 | trophon2 | Nanosonics | 2025-08-05 | 172 | 0 |
| K241536 | trophon Wireless Ultrasound Probe Holder | Nanosonics Limited | 2024-09-27 | 120 | 0 |
| K173865 | trophon2 | Nanosonics Limited | 2018-04-24 | 125 | 0 |
| K103059 | TROPHON | Nanosonics Limited | 2011-02-24 | 132 | 1 |
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