Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.A2026-01-281210
K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.A2025-08-133010
K230893Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.A2023-10-232060
K220538DolorClast RadialE.M.S Electro Medical Systems S.A2022-07-111360
K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A2019-10-202683
K191079Piezon Built-in Kit, Piezon Built-in Kit LEDE.M.S Electro Medical Systems S.A2019-08-161150
K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2019-05-29300
K182490Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-10-09280
K181997Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-08-30350
K181364Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-06-20280
K173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-01-10970
K171174PERIO-FLOW nozzleE.M.S Electro Medical Systems S.A2017-12-182410
K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.A2017-09-111400
K151912AIR-FLOW handy 3.0 PLUSE.M.S Electro Medical Systems S.A2016-02-032050
K140990EMS PIEZON 707 BIK AND PIEZON 707 BIK LEDE.M.S Electro Medical Systems S.A2015-02-273160
K132478AIR-FLOW HANDY 3.0E.M.S Electro Medical Systems S.A2014-04-112460
K132480AIR-FLOW HANDY 3.0 PERIOE.M.S Electro Medical Systems S.A2014-02-242000
K132445PIEZON 250E.M.S Electro Medical Systems S.A2013-12-061220
K132443PIEZON 150E.M.S Electro Medical Systems S.A2013-11-221080
K123038SWISS LITHOBREAKERE.M.S Electro Medical Systems S.A2013-01-161100
K110173EMS AIR-FLOW MASTER PIEZONE.M.S Electro Medical Systems S.A2011-04-07770
K093723EMS MINIMASTER LEDE.M.S Electro Medical Systems S.A2010-09-082790
K093000EMS PIEZON MASTER 700E.M.S Electro Medical Systems S.A2010-07-303050
K092289EMS AIR-FLOW HANDY PERIOE.M.S Electro Medical Systems S.A2009-10-20830
K082791EMS AIR-FLOW MASTERE.M.S Electro Medical Systems S.A2009-02-181480
K072146EMS PIEZON MASTER SURGERYE.M.S Electro Medical Systems S.A2007-12-181370
K071722DEEP BLUEE.M.S Electro Medical Systems S.A2007-08-10490
K050710MINIMASTER ULTRASONIC SCALERE.M.S Electro Medical Systems S.A2005-03-30120

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