Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Contour Electrodes, Inc. · 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) |
|---|---|---|---|---|---|
| K900682 | PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE | Contour Electrodes, Inc. | 1990-07-31 | 168 | 0 |
| K893245 | L30-LB- INFANT LIMB BAND | Contour Electrodes, Inc. | 1989-06-20 | 53 | 0 |
| K881085 | SOFT-E SERIES T-10 ACCUTRACE TAB RESTING ELECTRODE | Contour Electrodes, Inc. | 1988-04-11 | 34 | 0 |
| K871412 | CONTOUR SOFT-E SERIES CONDUCTIVE SOLID GEL ELECTRO | Contour Electrodes, Inc. | 1987-05-12 | 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