FDA applicant

Elidah, Inc.

Monroe, CT3 decisions2019–20260 recalls

FDA records 3 decisions for Elidah, Inc. (Monroe, CT) from 2019 to 2026: 3 510(k) clearances. All are in product code QAJ (Cutaneous Electrode Stimulator For Urinary…). Its devices cite 3 predicates, 2 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2023

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Elidah, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Elidah, Inc.’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

Elidah, Inc.

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?