Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cpac, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
559 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110867 | STERI-DENT, STERI-SURE | Cpac, Inc. | 2011-07-20 | 113 | 0 |
| K094026 | STERI-DENT, STERI-SURE | Cpac, Inc. | 2011-07-12 | 559 | 0 |
| K781486 | STERI-VAC POWER UNITS | Cpac, Inc. | 1978-09-27 | 30 | 0 |
| K771071 | PORTO-VAC | Cpac, Inc. | 1977-07-14 | 30 | 0 |
| K771070 | DRY HEAT STERILIZER | Cpac, Inc. | 1977-07-14 | 30 | 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