Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QKM · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
122 daysmedian FDA review time
295 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), | Terragene S.A. | 2024-04-05 | 266 | 0 |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical In | 3M Company | 2022-04-20 | 295 | 0 |
| K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | 2022-01-07 | 99 | 0 |
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical In | 3M Company | 2020-12-07 | 28 | 0 |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical In | 3M Healthcare | 2020-03-13 | 122 | 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