Atlas FDA

FEO

14 FDA 510(k) clearances · Product code

101 daysmedian time to decision
297 days90th percentile
14clearances measured

FDA profile

Official device name
Lithotriptor, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4480
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 66 · 2022: 30 · 2023: 39 · 2024: 221 · 2025: 356 · 2026: 214
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Swiss LthoClast Trilogy (K230893)E.M.S Electro Medical Systems S.A2023-10-23
Swiss LithoClast Trilogy (K182490)E.M.S Electro Medical Systems S.A2018-10-09
Swiss LithoClast Trilogy (K181997)E.M.S Electro Medical Systems S.A2018-08-30
Swiss LithoClast Trilogy (K181364)E.M.S Electro Medical Systems S.A2018-06-20
Swiss LithoClast Trilogy (K173234)E.M.S Electro Medical Systems S.A2018-01-10
ShockPulse-SE Lithotripsy System (K171024)Cybersonics, Inc.2017-08-21
Shock Pulse-SE Lithotripsy System CYBERWAND II (K142428)Cybersonics, Inc.2014-11-13
FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (K993046)Fibra Sonics, Inc.1999-11-22
KSEA CALCUSON (K973251)KARL STORZ Endoscopy-America, Inc.1998-06-22
ULTRASOUND GENERATOR MODLE 2270 (K920235)Richard Wolf Medical Instruments Corp.1992-12-07
OLYMPUS LUS ULTRASONIC LITHOTRIPTER (K873367)Olympus Corp.1987-11-30
ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM (K850298)Cabot Medical Corp.1985-03-05
ULTRASONIC LITHOTRIPTOR 300A (K842024)Fibra Sonics, Inc.1984-12-11
KARL STORZ 27086KC ULTRASONIC LITHOTRI (K843101)KARL STORZ Endoscopy-America, Inc.1984-12-11

Track FEO automatically

Every clearance here is in the API, with alerts when new ones post.