Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
(Ems Sa) Electro Medical Systems · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
184 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073284 | AIR-FLOW MASTER STANDARD | (Ems Sa) Electro Medical Systems | 2007-12-14 | 23 | 0 |
| K032099 | SWISS MASTER LIGHT | (Ems Sa) Electro Medical Systems | 2003-10-27 | 111 | 0 |
| K992504 | EMS KERMIT | (Ems Sa) Electro Medical Systems | 2000-01-27 | 184 | 0 |
| K991874 | EMS SURFACE MOUNT SCALER | (Ems Sa) Electro Medical Systems | 1999-07-30 | 58 | 0 |
| K991588 | EMS SWISS ORTHOCLAST | (Ems Sa) Electro Medical Systems | 1999-07-21 | 75 | 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