Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Sterilization Products, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
219 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology | Advanced Sterilization Products, Inc. | 2026-04-15 | 219 | 0 |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) | Advanced Sterilization Products, Inc. | 2025-04-14 | 31 | 0 |
| K234084 | STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEA | Advanced Sterilization Products, Inc. | 2024-07-05 | 196 | 0 |
| K220404 | STERRAD NX with ALLClear Technology | Advanced Sterilization Products, Inc. | 2022-05-16 | 91 | 0 |
| K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | Advanced Sterilization Products, Inc. | 2021-10-09 | 89 | 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