Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
E.M.S Electro Medical Systems S.A — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
301 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | 2026-01-28 | 121 | 0 |
| K243279 | DOLORCLAST Focused Shock Waves | E.M.S Electro Medical Systems S.A | 2025-08-13 | 301 | 0 |
| K230893 | Swiss LthoClast Trilogy | E.M.S Electro Medical Systems S.A | 2023-10-23 | 206 | 0 |
| K220538 | DolorClast Radial | E.M.S Electro Medical Systems S.A | 2022-07-11 | 136 | 0 |
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | 2019-10-20 | 268 | 3 |
| K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | E.M.S Electro Medical Systems S.A | 2019-08-16 | 115 | 0 |
| K191124 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2019-05-29 | 30 | 0 |
| K182490 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018-10-09 | 28 | 0 |
| K181997 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018-08-30 | 35 | 0 |
| K181364 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018-06-20 | 28 | 0 |
| K173234 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2018-01-10 | 97 | 0 |
| K171174 | PERIO-FLOW nozzle | E.M.S Electro Medical Systems S.A | 2017-12-18 | 241 | 0 |
| K171189 | AIR-FLOW PLUS Prophylaxis powder | E.M.S Electro Medical Systems S.A | 2017-09-11 | 140 | 0 |
| K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A | 2016-02-03 | 205 | 0 |
| K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | E.M.S Electro Medical Systems S.A | 2015-02-27 | 316 | 0 |
| K132478 | AIR-FLOW HANDY 3.0 | E.M.S Electro Medical Systems S.A | 2014-04-11 | 246 | 0 |
| K132480 | AIR-FLOW HANDY 3.0 PERIO | E.M.S Electro Medical Systems S.A | 2014-02-24 | 200 | 0 |
| K132445 | PIEZON 250 | E.M.S Electro Medical Systems S.A | 2013-12-06 | 122 | 0 |
| K132443 | PIEZON 150 | E.M.S Electro Medical Systems S.A | 2013-11-22 | 108 | 0 |
| K123038 | SWISS LITHOBREAKER | E.M.S Electro Medical Systems S.A | 2013-01-16 | 110 | 0 |
| K110173 | EMS AIR-FLOW MASTER PIEZON | E.M.S Electro Medical Systems S.A | 2011-04-07 | 77 | 0 |
| K093723 | EMS MINIMASTER LED | E.M.S Electro Medical Systems S.A | 2010-09-08 | 279 | 0 |
| K093000 | EMS PIEZON MASTER 700 | E.M.S Electro Medical Systems S.A | 2010-07-30 | 305 | 0 |
| K092289 | EMS AIR-FLOW HANDY PERIO | E.M.S Electro Medical Systems S.A | 2009-10-20 | 83 | 0 |
| K082791 | EMS AIR-FLOW MASTER | E.M.S Electro Medical Systems S.A | 2009-02-18 | 148 | 0 |
| K072146 | EMS PIEZON MASTER SURGERY | E.M.S Electro Medical Systems S.A | 2007-12-18 | 137 | 0 |
| K071722 | DEEP BLUE | E.M.S Electro Medical Systems S.A | 2007-08-10 | 49 | 0 |
| K050710 | MINIMASTER ULTRASONIC SCALER | E.M.S Electro Medical Systems S.A | 2005-03-30 | 12 | 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