Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ndm Acquisition Corp. — 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) |
|---|---|---|---|---|---|
| K943287 | ACT-ONE ADVANCED COMPRESSION TECHNOLOGY FOOT PUMP | Ndm Acquisition Corp. | 1994-12-27 | 172 | 0 |
| K934601 | NDM HYDROGAUZE WOUND DRESSING | Ndm Acquisition Corp. | 1994-02-15 | 144 | 0 |
| K931457 | NDM SILVON ECG ELECTRODES | Ndm Acquisition Corp. | 1993-11-23 | 245 | 0 |
| K914207 | CLEARSITE(R) STERILE WOUND CARE DRESSING | Ndm Acquisition Corp. | 1991-10-23 | 34 | 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