Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
LFN · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
31 daysmedian FDA review time
169 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934388 | QMS PHENOBARBITAL | Seradyn, Inc. | 1994-02-25 | 169 | 0 |
| K864612 | DART PHENOBARBITAL ASSAY SYSTEM | Coulter Electronics, Inc. | 1987-01-13 | 50 | 0 |
| K860303 | DUPONT PHENOBARBITAL CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 | 31 | 0 |
| K860304 | DUPONT PHENOBARBITAL ASSAY | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 | 31 | 0 |
| K821543 | IPA FOR DETECTION OF PHENOBARBITAL | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 | 10 | 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