Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PJJ — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
190 daysmedian FDA review time
293 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190260 | STERIZONE(R) VP4 Sterilizer | Tso3, Inc. | 2019-07-19 | 161 | 0 |
| K172191 | STERIZONE VP4 Sterilizer | Tso3, Inc. | 2018-05-09 | 293 | 0 |
| K173694 | STERIZONE VP4 Sterilizer | Tso3, Inc. | 2018-03-13 | 102 | 0 |
| K153689 | STERIZONE Sterilizer | Tso3, Inc. | 2016-06-30 | 190 | 0 |
| K153392 | STERIZONE VP4 Sterilizer | Ts03, Inc. | 2016-03-24 | 121 | 0 |
| K141163 | STERIZONE STERILIZER | Tso3, Inc. | 2014-12-17 | 226 | 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