Data / Medical devices / United States / Pumpables Inc.
Pumpables Inc.: FDA-registered device maker in Middletown, DE, United States, 1 510(k) clearance
Pumpables Inc. is registered with the FDA (registration 3020119717) in Middletown, DE, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020119717
- Address
- 651 N Broad St, Suite 206, Middletown, DE, United States, 19709
- Owner or operator
- Pumpables Inc. (10087540)
- Roles
- Specification developer
- First device listed
- March 13, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Powered | HGX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 6, 2022 | K212564 | Electric Breast Pump | HGX | Substantially Equivalent | Guangdong Horigen Mother & Baby Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 6, 2022. 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.