Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
National Medical Technology · 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) |
|---|---|---|---|---|---|
| K871668 | BIODAN TYPE COMET ELECTRODE | National Medical Technology | 1987-06-10 | 43 | 0 |
| K861158 | S&W TYPE 888 ELECTRODE | National Medical Technology | 1986-07-01 | 95 | 0 |
| K830888 | COOL-LITE FIBERCOPTIC LARYNGEAL EXAM | National Medical Technology | 1983-04-27 | 37 | 0 |
| K790845 | DUALUME LARYNGEAL EXAMINATION TELESCOPE | National Medical Technology | 1979-07-24 | 81 | 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