Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med-Western Electronics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
62 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K813100 | BIO-STIMULATOR, MODEL 400 | Med-Western Electronics, Inc. | 1981-11-27 | 24 | 0 |
| K810225 | LITRONIC STIMULATOR | Med-Western Electronics, Inc. | 1981-03-30 | 62 | 0 |
| K802217 | VIEW-LITE, MODEL-SL | Med-Western Electronics, Inc. | 1980-10-23 | 41 | 0 |
| K802216 | VIEW-LITE, MODEL-DL | Med-Western Electronics, Inc. | 1980-10-23 | 41 | 0 |
| K802215 | VIEW-LITE, MODEL-S | Med-Western Electronics, Inc. | 1980-10-23 | 41 | 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