Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FFK — Predicate Candidate Screening
61 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
277 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 | 175 | 0 |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 | 179 | 0 |
| K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | 2023-08-31 | 189 | 0 |
| K202813 | URO-TOUCH 9 French Probe | Northgate Technologies, Inc. | 2021-06-14 | 263 | 0 |
| K191124 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2019-05-29 | 30 | 0 |
| K162119 | UreTron PF Series Probe | Med-Sonics Corp. | 2016-08-29 | 28 | 0 |
| K160198 | UreTron MultiProbe Lithotripter System | Med-Sonics Corp. | 2016-02-23 | 26 | 0 |
| K132795 | CYBERWAND STERILE PROBE SET | Cybersonics, Inc. | 2013-11-26 | 81 | 0 |
| K130368 | AUTOLITH TOUCH; URO TOUCH | Northgate Technologies, Inc. | 2013-11-15 | 274 | 2 |
| K123038 | SWISS LITHOBREAKER | E.M.S Electro Medical Systems S.A | 2013-01-16 | 110 | 0 |
| K120303 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | Cybersonics, Inc. | 2012-06-05 | 125 | 0 |
| K111058 | URETRON MODEL URT | Med-Sonics Corp. | 2012-03-30 | 347 | 0 |
| K102169 | CYBERWAND LITHOTRIPTER | Cybersonics, Inc. | 2010-08-30 | 28 | 0 |
| K092033 | VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR | Elmed USA | 2010-04-30 | 298 | 0 |
| K072422 | CYBERWAND STERILE PADS, MODEL: CW-RBPBX | Cybersonics, Inc. | 2007-10-24 | 57 | 0 |
| K062475 | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM | The Laryngeal Mask Co., Ltd. | 2007-05-09 | 258 | 0 |
| K052135 | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER | Cybersonics, Inc. | 2005-12-20 | 137 | 1 |
| K011911 | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND | Richard Wolf Medical Instruments Corp. | 2001-09-17 | 90 | 1 |
| K011848 | CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE | Circon Video | 2001-09-11 | 90 | 0 |
| K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | Electro Medical Systems SA | 2001-08-24 | 23 | 3 |
| K011065 | INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTR | Richard Wolf Medical Instruments Corp. | 2001-05-09 | 30 | 1 |
| K002084 | MICROVASIVE LITHOTRIPTOR FLEXPROBE II | Boston Scientific Corp | 2000-07-19 | 9 | 0 |
| K992114 | KSEA CALCUSPLIT | Karl Storz Endoscopy | 1999-08-18 | 57 | 0 |
| K992251 | SWISS LITHOCLAST MULTIPURPOSE PROBE | Electro Medical Systems SA | 1999-07-27 | 21 | 0 |
| K990341 | ELECTRO MECHANICAL LITHOTRIPTOR | Northgate Technologies, Inc. | 1999-07-14 | 161 | 0 |
| K980492 | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, | Circon Acmi | 1998-11-17 | 281 | 4 |
| K981233 | KSEA CALCUSPLIT | KARL STORZ Endoscopy-America, Inc. | 1998-06-15 | 73 | 0 |
| K974796 | LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER | Medispec, Ltd. | 1998-03-12 | 80 | 0 |
| K973788 | MICROVASIVE LIPTHOTRIPSY PROBES | Boston Scientific Corp | 1998-01-21 | 107 | 0 |
| K974164 | SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE | Medical Device Consultants, Inc. | 1997-12-18 | 43 | 0 |
| K963285 | EMS SWISS LITHOCLAST LITHOTRIPTER | Electro Medical Systems SA | 1997-02-13 | 176 | 0 |
| K951531 | SWISS LITHOCLAST LITHOTRIPTER | Electro Medical Systems SA | 1995-08-24 | 143 | 0 |
| K944571 | PULSE GUARD 3FR ELECTRODE | Northgate Technologies, Inc. | 1995-03-17 | 179 | 0 |
| K931755 | RIWOLITH 2280 PROBES | Richard Wolf Medical Instruments Corp. | 1994-04-15 | 372 | 0 |
| K931779 | EHL PULSE GENERATOR | Psi Medical Products, Inc. | 1994-02-15 | 312 | 0 |
| K920410 | EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB | Psi Medical Products, Inc. | 1994-02-14 | 745 | 0 |
| K925396 | PULSE GUARD ELECTRODE | Northgate Technologies, Inc. | 1993-07-30 | 277 | 0 |
| K923822 | AUTOLITH-IEHL | Northgate Technologies, Inc. | 1993-01-28 | 182 | 0 |
| K914517 | SD-200IEHL(TM) | Northgate Technologies, Inc. | 1992-06-30 | 265 | 0 |
| K913487 | RIWOLITH 2280 | Richard Wolf Medical Instruments Corp. | 1992-02-05 | 183 | 0 |
| K914516 | 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1992-01-07 | 90 | 1 |
| K914515 | 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1992-01-07 | 90 | 0 |
| K914514 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1992-01-06 | 89 | 0 |
| K913955 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | 1991-11-29 | 85 | 0 |
| K905553 | LITHOTRIPTOR SYSTEM MODEL 27080 | Karl Storz GmbH & Co. (Kst) | 1991-06-04 | 175 | 0 |
| K903337 | 1.9 FRENCH LITHOTRIPTER ELECTRODE | Northgate Research, Inc. | 1990-11-16 | 114 | 0 |
| K894704 | 2.5 FRENCH LITHOTRIPTOR ELECTRODE | Northgate Research, Inc. | 1989-10-18 | 85 | 0 |
| K895178 | TECHNOMED PULSOLITH LASER SYSTEM | Teknomed, Inc. | 1989-10-06 | 57 | 0 |
| K885255 | MDL-1 LASERTRIPTER(TM) | Candela Laser Corp. | 1989-06-01 | 160 | 0 |
| K890436 | TECHNOMED PULSOLITH LASER SYSTEM | Teknomed, Inc. | 1989-03-23 | 55 | 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