Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Electro Medical Systems SA — Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

51 daysmedian FDA review time

176 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K022328	EMS PIEZON MASTER 600	Electro Medical Systems SA	2002-08-13	26	0
K022119	EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE	Electro Medical Systems SA	2002-07-25	24	0
K012445	EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)	Electro Medical Systems SA	2001-08-24	23	3
K002484	EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REM	Electro Medical Systems SA	2000-10-04	51	0
K992251	SWISS LITHOCLAST MULTIPURPOSE PROBE	Electro Medical Systems SA	1999-07-27	21	0
K963285	EMS SWISS LITHOCLAST LITHOTRIPTER	Electro Medical Systems SA	1997-02-13	176	0
K964111	LITHOVAC SUCTION/ASPIRATION PROBE	Electro Medical Systems SA	1996-12-16	62	0
K953026	MINIPIEZON	Electro Medical Systems SA	1995-08-28	60	0
K951531	SWISS LITHOCLAST LITHOTRIPTER	Electro Medical Systems SA	1995-08-24	143	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