FDA applicant

Hersill, S.L.

Mostoles ( Madrid), ES2 decisions2010–20100 recalls

FDA records 2 decisions for Hersill, S.L. (Mostoles ( Madrid), ES) in 2010: 2 510(k) clearances. Most are in product codes BTA (Pump, Portable, Aspiration (Manual Or Powered)) and BTM (Ventilator, Emergency, Manual (Resuscitator)). Its devices cite 7 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, general and plastic surgery panel, where it files most

How often FDA has decided Hersill, S.L.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

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

Planning a device like Hersill, S.L.’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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Hersill, S.L.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?