510(k) Report

FDA applicant

Sonokinetics, Inc.

Hoboken, NJ3 decisions1991–19990 recalls

FDA records 3 decisions for Sonokinetics, Inc. (Hoboken, NJ) from 1991 to 1999: 3 510(k) clearances. Most are in product codes LFL (Instrument, Ultrasonic Surgical) and LZV (System, Cement Removal Extraction). Its devices cite 7 predicates, 1 of them its own earlier devices. No 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Sonokinetics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sonokinetics, 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?

  • LFLInstrument, Ultrasonic Surgical1decision
  • LZVSystem, Cement Removal Extraction1decision
  • JDXInstrument, Surgical, Sonic And Accessory/Attachment1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K990572SonotomeSonokinetics, Inc. · 19992cite it
  • K930629Acryl-X II SystemSonokinetics, Inc. · 19941cites it

What has FDA decided for it lately?

  • K990572SonotomeSonokinetics, Inc. · 1999
  • K930629Acryl-X II SystemSonokinetics, Inc. · 1994
  • K911548Acryl-X System TMSonokinetics, Inc. · 1991

All 3 as Sonokinetics, Inc. →