Data / Medical devices / United States / Hygeia Ii Medical Group, Inc.
Hygeia Ii Medical Group, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 7 510(k) clearances
Hygeia Ii Medical Group, Inc. is registered with the FDA (registration 3006774448) in Carlsbad, CA, United States. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 11, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006774448
- Address
- 6241 Yarrow Dr Ste A, Carlsbad, CA, United States, 92011
- Owner or operator
- Hygeia II Medical Group, Inc. (10025094)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 12, 2009
- Registered through
- 2026
- Brand names listed
- EVOLVE, EXPRESS LITE, EnDeare, EnHande Manual Breast Pump, EnJoye, EnRiche, Hygeia 2 Hand Manual Breast Pump, Hygeia Express Powered Breast Pump and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Breast, Non-Powered | HGY | 1 | Specification developer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 11, 2024 | K241004 | Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) | HGX | Substantially Equivalent | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. | accessdata.fda.gov |
| March 13, 2024 | K233136 | Hygeia Express Powered Breast Pump | HGX | Substantially Equivalent | Hygeia II Medical Group, Inc. | accessdata.fda.gov |
| March 15, 2022 | K212955 | Fit Pro Breast Pump | HGX | Substantially Equivalent | Hygeia II Medical Group, Inc. | accessdata.fda.gov |
| March 18, 2020 | K200406 | Evolve Breast Pump | HGX | Substantially Equivalent | Hygeia II Medical Group, Inc. | accessdata.fda.gov |
| October 18, 2019 | K190465 | Evolve Breast Pump | HGX | Substantially Equivalent | Hygeia II Medical Group, Inc. | accessdata.fda.gov |
| March 7, 2017 | K162870 | CIMLRE F1 and CIMILRE S3 | HGX | Substantially Equivalent | Cimilre Co., Ltd. | accessdata.fda.gov |
| January 22, 2009 | K081932 | ENDEARE BREAST PUMP | HGX | Substantially Equivalent | Hygeia Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 11, 2024. 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.