Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DLI · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
95 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950180 | DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-15 | 57 | 0 |
| K930208 | CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO | Heraeus Kulzer, Inc. | 1993-04-20 | 95 | 0 |
| K860350 | SERUM CHOLINESTERASE REAGENT SET | Sterling Diagnostics, Inc. | 1986-04-24 | 84 | 0 |
| K860641 | EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 | Em Diagnostic Systems, Inc. | 1986-04-03 | 42 | 0 |
| K833062 | SERUM CHOLINESTERASE REAGENT SET | Sterling Biochemical, Inc. | 1983-11-25 | 78 | 0 |
| K771024 | CHOLINESTERASE REAGENT SYSTEM | American Monitor Corp. | 1977-07-15 | 37 | 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