Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Damor America, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933328 | DAMOR CREME | Damor America, Inc. | 1993-12-07 | 152 | 0 |
| K934267 | DAMOR CREAM SATURATED DRESSING | Damor America, Inc. | 1993-12-07 | 98 | 0 |
| K901022 | POWERED INFLATABLE TUBE MASSAGER, SPORT-MED | Damor America, Inc. | 1990-03-14 | 9 | 0 |
| K891097 | DAMOR CREAM SATURATED DRESSING | Damor America, Inc. | 1989-08-25 | 176 | 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