Data / Medical devices / United States / A Cute Baby, Inc.
A Cute Baby, Inc.: FDA-registered device maker in Orem, UT, United States, 3 510(k) clearances
A Cute Baby, Inc. is registered with the FDA (registration 3009243271) in Orem, UT, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 12, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009243271
- Address
- 865 N 1430 W, Orem, UT, United States, 84057
- Owner or operator
- A Cute Baby, Inc. (10038874)
- Roles
- Complaint file establishment
- First device listed
- March 18, 2014
- Registered through
- 2026
- Brand names listed
- A Cute Baby, Amaris, Drive, Medquip, Rumble Tuff, Viverity
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Non-Powered | HGY | 1 | Complaint file establishment | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 2026 | K252583 | Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | HGX | Substantially Equivalent | A Cute Baby, Inc. | accessdata.fda.gov |
| April 17, 2020 | K200712 | Rumble Tuff Electric Breast Pump | HGX | Substantially Equivalent | A Cute Baby, Inc. | accessdata.fda.gov |
| November 20, 2012 | K113315 | RUMBLE TUFF | HGX | Substantially Equivalent | Acute Ideas Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.