Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dna Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
57 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833659 | IV EXTENSION SET | Dna Medical, Inc. | 1983-11-29 | 42 | 0 |
| K832878 | GOAL TENDER | Dna Medical, Inc. | 1983-10-14 | 49 | 0 |
| K822891 | FLO CONTROL | Dna Medical, Inc. | 1982-11-24 | 57 | 0 |
| K821929 | SUBCLAVIAN | Dna Medical, Inc. | 1982-07-08 | 9 | 0 |
| K820628 | J-CATHETER | Dna Medical, Inc. | 1982-04-06 | 29 | 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