Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nieusma R & D, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892882 | DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 | Nieusma R & D, Inc. | 1989-06-23 | 78 | 0 |
| K892881 | DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 | Nieusma R & D, Inc. | 1989-06-23 | 78 | 0 |
| K885299 | SANI-SLEEVE DRAPE FOR DENTAL USE | Nieusma R & D, Inc. | 1989-03-16 | 79 | 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