FDA applicant

Spiracur, Inc.

Sunnyvale, CA9 decisions2009–20150 recalls

FDA records 9 decisions for Spiracur, Inc. (Sunnyvale, CA) from 2009 to 2015: 8 510(k) clearances and 1 De Novo grant. All are in product code OKO (Negative Pressure Wound Therapy Non-Powered…). Its devices cite 16 predicates, 12 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2015

2009high 4 (2011) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Spiracur, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spiracur, 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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Spiracur, 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?