Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DEX · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
31 daysmedian FDA review time
56 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823765 | ANTI SERA TO HUMAN OROSCOMUCOID | Kent Laboratories, Inc. | 1982-12-30 | 16 | 0 |
| K801909 | LSA 290 ASSAY REAGENTS/NEPHELOMETRIC | J.T. Baker Chemical Co. | 1980-09-26 | 46 | 0 |
| K791341 | HUMAN ALPHA, ACID GLYCOPROTEIN | Beckman Instruments, Inc. | 1979-08-16 | 31 | 0 |
| K781023 | ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU | Icl Scientific | 1978-08-14 | 56 | 0 |
| K760143 | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | Oxford Laboratories, Inc. | 1976-07-20 | 21 | 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