Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DPA — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
182 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904326 | DE-TOX TUBES A AND DE-TOX TUBES B | Dyna-Tek Industries | 1991-01-17 | 119 | 0 |
| K884176 | CHROMATOGRAPHY KIT | Gelman Sciences, Inc. | 1989-04-04 | 182 | 0 |
| K791431 | TECHNICON FAST-LC SYS. FOR THEOPHYLLINE | Technicon Instruments Corp. | 1979-10-11 | 77 | 0 |
| K770765 | REAGENT SET, RENORPACE | G.D. Searle and Co. | 1977-06-24 | 58 | 0 |
| K760908 | MINIATURE ASCENDING PAPER CHROMATO- | Ackerman Nuclear, Inc. | 1976-11-19 | 24 | 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