510(k) Report

FDA applicant

Medstone Intl., Inc.

Aliso Viejo5 decisions1988–20021 recall

FDA records 5 decisions for Medstone Intl., Inc. (Aliso Viejo) from 1988 to 2002: 3 510(k) clearances and 2 original PMA approvals. Most are in product codes LNS (Lithotriptor, Extracorporeal Shock-Wave…) and NCV (Lithotripter, Shockwave (For Treating…). 1 recall is 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 Medstone Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medstone Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • LNSLithotriptor, Extracorporeal Shock-Wave, Urological2decisions
  • NCVLithotripter, Shockwave (For Treating Gallbladder Stones)1decision
  • IZFSystem, X-Ray, Tomographic1decision
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision

What has FDA decided for it lately?

  • K013620Medstone, Uropro 2000, Tomographic OptionMedstone Intl., Inc. · 2002
  • K010900STS-T Lithotripter, Model STS-TMedstone Intl., Inc. · 2001
  • P970042Medstone STS LithotripterMedstone Intl., Inc. · 2000
  • K905278STS (TM) Fluoroscopic Imaging ModuleMedstone Intl., Inc. · 1991
  • P870015Medstone 1050 Ectracorporeal Shock Wave LithotriptMedstone Intl., Inc. · 19881 recall

All 5 as Medstone Intl., Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • P870015STS-T Mobile x-ray system used with the STS-T lithotripter.Jun 11, 2004