FDA applicant

Guard Medical, Inc.

Miami, FL7 decisions2020–20250 recalls

FDA records 7 decisions for Guard Medical, Inc. (Miami, FL) from 2020 to 2025: 7 510(k) clearances. All are in product code OKO (Negative Pressure Wound Therapy Non-Powered…). Its devices cite 7 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 and plastic surgery panel, where it files most

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

FDA decisions per year

2in 2025

2020high 2 (2024) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Guard Medical, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Guard Medical, 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

Guard Medical, 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?