FDA applicant

Stealth Therapeutics, Incorporated

Stoughton, WI2 decisions2011–20150 recalls

FDA records 2 decisions for Stealth Therapeutics, Incorporated (Stoughton, WI) from 2011 to 2015: 2 510(k) clearances. All are in product code LJT (Port & Catheter, Implanted, Subcutaneous…). Its devices cite 5 predicates, 1 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 hospital panel, where it files most

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

FDA decisions per year

1in 2015

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Stealth Therapeutics, Incorporated by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Stealth”

FDA records each applicant name separately; these may or may not be the same firm.

Stealth Products 1

Stealth Therapeutics, Incorporated

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Stealth”