Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medispec, Ltd. — 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) |
|---|---|---|---|---|---|
| K210166 | Omnispec ED1000 | Medispec, Ltd. | 2023-01-27 | 736 | 0 |
| K063504 | ECONOLITH EM1000 | Medispec, Ltd. | 2007-03-09 | 109 | 0 |
| K040461 | ECONOLITH E3000, MODEL 3000 (SW-6) | Medispec, Ltd. | 2004-05-25 | 92 | 0 |
| K974796 | LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER | Medispec, Ltd. | 1998-03-12 | 80 | 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