510(k) Report

FDA applicant

Simavita Pty Limited

Washington, DC1 decision2013–20130 recalls

FDA records 1 decision for Simavita Pty Limited (Washington, DC) in 2013: 1 510(k) clearance. All are in product code KPN (Alarm, Conditioned Response Enuresis). Its devices cite 1 predicate, 0 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, gastroenterology and urology panel, where it files most

How often FDA has decided Simavita Pty Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Simavita Pty Limited by year, 2013–2026Sources: 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 Enuresis1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K130951SIMSimavita Pty Limited · 2013

The one decision as Simavita Pty Limited →