510(k) Report

FDA applicant

Health Sense Intl., Inc.

Washington, DC4 decisions1991–19960 recalls

FDA records 4 decisions for Health Sense Intl., Inc. (Washington, DC) from 1991 to 1996: 4 510(k) clearances. All are in product code KPN (Alarm, Conditioned Response Enuresis). 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 Health Sense Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Health Sense Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Health Sense 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?

  • KPNAlarm, Conditioned Response Enuresis4decisions

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K955338Drytime for Potty TrainingHealth Sense Intl., Inc. · 19961cites it
  • K943559Remote A'lertHealth Sense Intl., Inc. · 19951cites it

What has FDA decided for it lately?

  • K955338Drytime for Potty TrainingHealth Sense Intl., Inc. · 1996
  • K943558Pro'tectHealth Sense Intl., Inc. · 1995
  • K943559Remote A'lertHealth Sense Intl., Inc. · 1995
  • K911279Dry TimeHealth Sense Intl., Inc. · 1991

All 4 as Health Sense Intl., Inc. →