FDA applicant

Heartland Health Products

Cincinnati, OH1 decision2022–20220 recalls

FDA records 1 decision for Heartland Health Products (Cincinnati, OH) in 2022: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). 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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2022

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Heartland Health Products by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heartland Health Products’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 “Heartland”

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

Heartland Tanning, Inc. 1 Heartland Tan Systems 1 Heartland Medical Systems, Inc. 1

Heartland Health Products

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Heartland”