Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Primus Sterilizer Company, LLC — 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) |
|---|---|---|---|---|---|
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | 2023-12-19 | 83 | 0 |
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | Primus Sterilizer Company, LLC | 2023-02-10 | 266 | 0 |
| K093333 | PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL S | Primus Sterilizer Company, LLC | 2010-04-02 | 158 | 0 |
| K082817 | PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M | Primus Sterilizer Company, LLC | 2009-05-21 | 238 | 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