Data / Medical devices / United States / Pixie Cup LLC
Pixie Cup LLC: FDA-registered device maker in Walnut Shade, MO, United States, 3 510(k) clearances
Pixie Cup LLC is registered with the FDA (registration 3013865802) in Walnut Shade, MO, United States. It lists 11 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 13, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013865802
- Address
- 370 Gaar RD, Walnut Shade, MO, United States, 65771
- Owner or operator
- PIXIE CUP LLC (10061419)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 16, 2019
- Registered through
- 2026
- Brand names listed
- Dot Cup, Menstrual Cup Steamer, Pixie, Pixie Cup, Pixie Organic Cotton Tampons, Pixie Pulse Replacement Gel Pads, Pixie Reusable Pads, Pixie Womens Core Strength Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Vaginal | HGD | 1 | Specification developer | accessdata.fda.gov |
| Cup, Menstrual | HHE | 2 | Specification developer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Specification developer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Specification developer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Reusable | NUQ | 1 | Specification developer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Specification developer | accessdata.fda.gov |
| Pelvimeter, External | HER | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Specification developer | accessdata.fda.gov |
| Tampon, Menstrual, Unscented | HEB | 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 |
|---|---|---|---|---|---|---|
| August 13, 2025 | K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | HEB | Substantially Equivalent | Unibeauty (Hubei) Technology Co., Ltd. | accessdata.fda.gov |
| August 12, 2024 | K241365 | Pixie Pulse (SM9068) | NUH | Substantially Equivalent | Pixie Cup, LLC | accessdata.fda.gov |
| June 23, 2015 | K142786 | Ontex Unscented Tampons with Colored Plastic Applicators | HEB | Substantially Equivalent | Ontex Bvba | accessdata.fda.gov |
Compare with other makers
- All makers of Tampon, Menstrual, Unscented
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Pad, Heating, Powered
- All makers of Lubricant, Patient
- All makers of Pad, Menstrual, Unscented
- All makers of Pack, Hot Or Cold, Disposable
Updated August 13, 2025. 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.