510(k) Report

FDA applicant

Biosonics, Inc.

Philadelphia, PA4 decisions1986–19880 recalls

FDA records 4 decisions for Biosonics, Inc. (Philadelphia, PA) from 1986 to 1988: 3 510(k) clearances and 1 original PMA approval. Most are in product codes KPN (Alarm, Conditioned Response Enuresis) and LTF (Stimulator, Salivary System). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Biosonics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KPNAlarm, Conditioned Response Enuresis3decisions
  • LTFStimulator, Salivary System1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • P860067Salitron SystemBiosonics, Inc. · 19881cites it

What has FDA decided for it lately?

  • K882555Anotron (R) Incontinence Control SystemBiosonics, Inc. · 1988
  • P860067Salitron SystemBiosonics, Inc. · 1988
  • K864448The Biosonics Continence Control System CCS (TM)Biosonics, Inc. · 1987
  • K862683Biosoics Sphincter Training SystemBiosonics, Inc. · 1986

All 4 as Biosonics, Inc. →