FDA applicant

Siesta Medical, Inc.

Los Gatos, CA10 decisions2010–20210 recalls

FDA records 10 decisions for Siesta Medical, Inc. (Los Gatos, CA) from 2010 to 2021: 10 510(k) clearances. All are in product code ORY (Tongue Suspension System). Its devices cite 12 predicates, 9 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, dental panel, where it files most

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

FDA decisions per year

1in 2021

2010high 2 (2010) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Siesta Medical, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Siesta Medical, 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

Other applicant names beginning “Siesta”

FDA records each applicant name separately; these may or may not be the same firm.

The Siesta Group North America 1

Siesta Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Siesta”