Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Sterilization Products (Asp) — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
350 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Devi | Advanced Sterilization Products (Asp) | 2020-01-23 | 178 | 0 |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(T | Advanced Sterilization Products (Asp) | 2019-04-23 | 323 | 0 |
| K182404 | STERRAD VELOCITY Biological Indicator | Advanced Sterilization Products (Asp) | 2018-12-27 | 114 | 0 |
| K170039 | STERRAD VELOCITY Biological Indictator and Reader | Advanced Sterilization Products (Asp) | 2017-06-20 | 166 | 0 |
| K152189 | EVOTECH ECR | Advanced Sterilization Products (Asp) | 2016-07-20 | 350 | 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