Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Daum Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
88 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990278 | DAUM NEUROCUT NEUROBIOPSYNEEDLE | Daum Corp. | 1999-03-30 | 61 | 0 |
| K981320 | DAUM BONE BIOPSY SET | Daum Corp. | 1998-06-29 | 80 | 0 |
| K974631 | DAUM NEUROBIOPSY NEEDLE | Daum Corp. | 1998-03-09 | 87 | 0 |
| K974576 | DAUM BIOPSYGUN | Daum Corp. | 1998-03-06 | 88 | 0 |
| K974574 | DAUM NEUROPUNCTURE NEEDLE | Daum Corp. | 1998-03-06 | 88 | 0 |
| K974575 | DAUM ASPIRATIONBIOPSY NEEDLE | Daum Corp. | 1998-03-06 | 88 | 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