510(k) Report

FDA applicant

Insera Therapeutics, Inc.

Dallas, TX1 decision2026–20260 recalls

FDA records 1 decision for Insera Therapeutics, Inc. (Dallas, TX) in 2026: 1 510(k) clearance. Its devices cite 1 predicate, 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

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

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

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Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K253404CLEAR™ Aspiration SystemInsera Therapeutics, Inc. · 2026

The one decision as Insera Therapeutics, Inc. →