FDA applicant

Welldoc, Inc.

Columbia, MD11 decisions2010–20230 recalls

FDA records 11 decisions for Welldoc, Inc. (Columbia, MD) from 2010 to 2023: 11 510(k) clearances. Most are in product codes MRZ (Accessories, Pump, Infusion) and NDC (Calculator, Drug Dose). Its devices cite 10 predicates, 6 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 Welldoc, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2010high 2 (2023) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

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

Planning a device like Welldoc, 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

Welldoc, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?