Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micro-Shev , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
164 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913785 | CORONET 100 | Micro-Shev , Ltd. | 1991-12-31 | 130 | 0 |
| K900378 | EMG OPTION FOR MICROSHEV 4000 | Micro-Shev , Ltd. | 1990-04-10 | 74 | 0 |
| K894608 | MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM | Micro-Shev , Ltd. | 1989-12-29 | 164 | 0 |
| K874193 | MICROSHEV MODEL 2000 | Micro-Shev , Ltd. | 1988-03-21 | 159 | 0 |
| K792085 | C-ERA-100 COMPUTERIZED ELECTRIC RESPON | Micro-Shev , Ltd. | 1979-10-30 | 13 | 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