FDA applicant

Aspire Bariatrics, Inc.

King Of Prussia, PA3 decisions2016–20180 recalls

FDA records 3 decisions for Aspire Bariatrics, Inc. (King Of Prussia, PA) from 2016 to 2018: 2 510(k) clearances and 1 original PMA approval. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and OYF (Aspiration Therapy System). Its devices cite 4 predicates, 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 Aspire Bariatrics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2016high 2 (2018) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Aspire Bariatrics, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aspire Bariatrics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Aspire Bariatrics, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?