FDA applicant

Hygeia II Medical Group, Inc.

Carlsbad, CA4 decisions2019–20240 recalls

FDA records 4 decisions for Hygeia II Medical Group, Inc. (Carlsbad, CA) from 2019 to 2024: 4 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 174 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 4 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2024

2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

Planning a device like Hygeia II Medical Group, 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

Other applicant names beginning “Hygeia”

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

Hygeia Sciences 4 Hygeia, Ltd. 2 Hygeia Medical, Inc. 1

Hygeia II Medical Group, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Hygeia”