Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Denley Instruments, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
148 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K922803 | WELLWASH 4 MARK II | Denley Instruments, Inc. | 1992-11-05 | 148 | 0 |
| K922327 | DENLEY WELLPREP 2 SAMPLE PROCESSOR | Denley Instruments, Inc. | 1992-08-12 | 93 | 0 |
| K922183 | WELLPREP 2000 SAMPLE PROCESSOR | Denley Instruments, Inc. | 1992-08-11 | 92 | 0 |
| K915284 | STACKING MICROPLATE WASHER | Denley Instruments, Inc. | 1992-01-22 | 58 | 0 |
| K913567 | WELLPREP 1 | Denley Instruments, Inc. | 1991-10-04 | 56 | 0 |
| K900599 | MICROPLATE REAGENT DISPENSER | Denley Instruments, Inc. | 1990-05-17 | 98 | 0 |
| K894270 | DENLEY ANTHOS 2001 READER | Denley Instruments, Inc. | 1989-08-21 | 60 | 0 |
| K894272 | DENLEY WELLDILL 3 | Denley Instruments, Inc. | 1989-08-21 | 60 | 0 |
| K894271 | DENLEY WELLWASH 2 AND 4 | Denley Instruments, Inc. | 1989-08-15 | 54 | 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