Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
D.L. Nelson and Assoc., Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K944238 | ENDOCYTE TM | D.L. Nelson and Assoc., Inc. | 1995-09-15 | 380 | 0 |
| K945415 | 'LIL MAC ACCESSORY CLAMP(TM) | D.L. Nelson and Assoc., Inc. | 1994-11-22 | 15 | 0 |
| K925035 | MIDKIFF GEOSTATIC CLAMP | D.L. Nelson and Assoc., Inc. | 1993-02-18 | 136 | 0 |
| K904826 | TKO TELESCOPING LITHOTOMY STIRRUP | D.L. Nelson and Assoc., Inc. | 1990-10-31 | 6 | 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