FDA applicant

A Cute Baby, Inc.

Orem, UT2 decisions2020–20260 recalls

FDA records 2 decisions for A Cute Baby, Inc. (Orem, UT) from 2020 to 2026: 2 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Its devices cite 2 predicates, 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

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

Planning a device like A Cute Baby, 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

A Cute Baby, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?