Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Custom Ultrasonics — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122172 | SYSTEM 83 PLUS | Custom Ultrasonics | 2013-01-25 | 186 | 1 |
| K061430 | SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR | Custom Ultrasonics | 2007-01-12 | 234 | 1 |
| K983017 | MODIFICATION TO SYSTEM 83 PLUS | Custom Ultrasonics | 1998-09-22 | 25 | 2 |
| K842754 | CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 | Custom Ultrasonics | 1984-11-28 | 135 | 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