Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ars Enterprises, Inc. — 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) |
|---|---|---|---|---|---|
| K852115 | ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER | Ars Enterprises, Inc. | 1985-11-01 | 170 | 0 |
| K852113 | ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 | Ars Enterprises, Inc. | 1985-09-27 | 135 | 0 |
| K852114 | ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000 | Ars Enterprises, Inc. | 1985-09-27 | 135 | 0 |
| K831356 | STEAM STERILIZER | Ars Enterprises, Inc. | 1984-07-18 | 449 | 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