Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ndm Corp. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
25 daysmedian FDA review time
58 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K926202 | CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI | Ndm Corp. | 1993-05-12 | 154 | 0 |
| K901145 | NDM SWITCHPEN HOLSTER | Ndm Corp. | 1990-05-09 | 58 | 0 |
| K853968 | DIATEMP ELECTROSURGICAL PEN | Ndm Corp. | 1985-11-14 | 49 | 0 |
| K830663 | PENCIL SKIN ABRADER | Ndm Corp. | 1983-04-28 | 56 | 0 |
| K810920 | NDM DIATEMP INFANT ELECTROSURG. DISP. P. | Ndm Corp. | 1981-05-01 | 25 | 0 |
| K801158 | NDM DIATEMP ELECTROSURGICAL DIS. PAD | Ndm Corp. | 1980-05-23 | 9 | 0 |
| K790730 | NDM PAPER TAPE ECG ELECTRODE | Ndm Corp. | 1979-04-26 | 13 | 0 |
| K772354 | I.V. CATHETER | Ndm Corp. | 1978-01-31 | 35 | 0 |
| K772160 | ELECTROSURGICAL GROUNDING PAD | Ndm Corp. | 1977-11-28 | 12 | 0 |
| K761301 | V-TRACE ECG BACKPAD | Ndm Corp. | 1977-01-05 | 14 | 0 |
| K760312 | ELECTRODE, PNS | Ndm Corp. | 1976-08-04 | 9 | 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