Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Calgon Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
200 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944950 | KLENZYME | Calgon Corp. | 1994-12-20 | 74 | 0 |
| K943364 | CORASSIST WOUND DRESSING | Calgon Corp. | 1994-08-03 | 21 | 0 |
| K940263 | NPH-KLENZ | Calgon Corp. | 1994-05-18 | 117 | 0 |
| K935063 | INSTRU KLENZ | Calgon Corp. | 1994-05-09 | 200 | 0 |
| K940407 | KALTOGEL WOUND DRESSING | Calgon Corp. | 1994-04-07 | 70 | 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