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

FEO — Predicate Candidate Screening

14 FDA 510(k) clearances under this product code; the 50 most recent screened below.

101 daysmedian FDA review time

297 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K230893	Swiss LthoClast Trilogy	E.M.S Electro Medical Systems S.A	2023-10-23	206	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
K171024	ShockPulse-SE Lithotripsy System	Cybersonics, Inc.	2017-08-21	138	5
K142428	Shock Pulse-SE Lithotripsy System CYBERWAND II	Cybersonics, Inc.	2014-11-13	76	0
K993046	FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-20	Fibra Sonics, Inc.	1999-11-22	73	0
K973251	KSEA CALCUSON	KARL STORZ Endoscopy-America, Inc.	1998-06-22	297	0
K920235	ULTRASOUND GENERATOR MODLE 2270	Richard Wolf Medical Instruments Corp.	1992-12-07	325	0
K873367	OLYMPUS LUS ULTRASONIC LITHOTRIPTER	Olympus Corp.	1987-11-30	101	0
K850298	ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM	Cabot Medical Corp.	1985-03-05	40	0
K842024	ULTRASONIC LITHOTRIPTOR 300A	Fibra Sonics, Inc.	1984-12-11	207	0
K843101	KARL STORZ 27086KC ULTRASONIC LITHOTRI	KARL STORZ Endoscopy-America, Inc.	1984-12-11	126	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