FDA applicant

Respicardia

Minnetonka, MN2 decisions2013–20170 recalls

FDA records 2 decisions for Respicardia (Minnetonka, MN) from 2013 to 2017: 1 510(k) clearance and 1 original PMA approval. Most are in product codes DQY (Catheter, Percutaneous) and PSR (Implanted Phrenic Nerve Stimulator For Central…). Its devices cite 3 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2017

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Respicardia by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Respicardia’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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Respicardia

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?