Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ni-Med, 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) |
|---|---|---|---|---|---|
| K981910 | SUCTION CATHETER | Ni-Med, Inc. | 1998-08-24 | 84 | 0 |
| K875315 | I.V. START KITS | Ni-Med, Inc. | 1988-02-17 | 50 | 0 |
| K872824 | P. URINE METER, 250CC | Ni-Med, Inc. | 1987-10-14 | 90 | 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