510(k) Report

FDA applicant

Cybersonics, Inc.

Erie, PA7 decisions2005–20178 recalls

FDA records 7 decisions for Cybersonics, Inc. (Erie, PA) from 2005 to 2017: 7 510(k) clearances. Most are in product codes FFK (Lithotriptor, Electro-Hydraulic) and FEO (Lithotriptor, Ultrasonic). Its devices cite 9 predicates, 7 of them its own earlier devices. 8 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Cybersonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007: 12010: 12012: 12013: 12014: 12017: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2026

2007: 12020: 12022: 12025: 42026 (partial year): 1
2007high 4 (2025) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Cybersonics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cybersonics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FFKLithotriptor, Electro-Hydraulic5decisions
  • FEOLithotriptor, Ultrasonic2decisions

Whose devices does it build on?

Its devices cite 9 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K052135Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 20053cite it
  • K102169Cyberwand LithotripterCybersonics, Inc. · 20102cite it
  • K120303Cyberwand Dual Action Ultrasonic Lithotripsy SystemCybersonics, Inc. · 20122cite it
  • K142428Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc. · 20141cites it
  • K072422Cyberwand Sterile Pads, Model: CW-RbpbxCybersonics, Inc. · 20071cites it

What has FDA decided for it lately?

  • K171024ShockPulse-SE Lithotripsy SystemCybersonics, Inc. · 20176 recalls
  • K142428Shock Pulse-SE Lithotripsy System CYBERWAND IICybersonics, Inc. · 20141 recall
  • K132795Cyberwand Sterile Probe SetCybersonics, Inc. · 2013
  • K120303Cyberwand Dual Action Ultrasonic Lithotripsy SystemCybersonics, Inc. · 2012
  • K102169Cyberwand LithotripterCybersonics, Inc. · 2010
  • K072422Cyberwand Sterile Pads, Model: CW-RbpbxCybersonics, Inc. · 2007
  • K052135Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 20051 recall

All 7 as Cybersonics, Inc. →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K171024Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name…Jan 8, 2026Class II
  • K171024Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy…Nov 14, 2025Class II
  • K171024Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE…Nov 14, 2025Class II
  • K171024Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE…Nov 14, 2025Class II
  • K171024Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer…Oct 8, 2025Class II
  • K171024ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-SJul 7, 2022Class II