Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
National Wire & Stamping, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
351 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940191 | ELECTROSURGICAL LOOP ELECTRODE | National Wire & Stamping, Inc. | 1994-12-30 | 351 | 0 |
| K940192 | MIS ELECTROSURGICAL ELECTRODES | National Wire & Stamping, Inc. | 1994-04-19 | 96 | 0 |
| K861595 | BALL ELECTRODES | National Wire & Stamping, Inc. | 1986-06-19 | 51 | 0 |
| K861495 | ELECTROSURGICAL BLADE ELECTRODE (SOLID TYPE) | National Wire & Stamping, Inc. | 1986-06-19 | 58 | 0 |
| K861594 | ELECTROSURGICAL NEEDLE ELECTRODE (SOLID TYPE) | National Wire & Stamping, Inc. | 1986-06-19 | 51 | 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