Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013865802

FEI Number

3013865802

Entity Name

PIXIE CUP LLC

City/State/Country

Walnut Shade, MO, US

Establishment Address

370 GAAR RD, Walnut Shade, MO 65771, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

PIXIE CUP LLC (Owner Number: 10061419)

Owner / Operator Contact Address

370 GAAR RD, Walnut Shade, MO 65771, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pixie Cup Pixie Pixie Cup Pixie Reusable Pads Pixie Womens Core Strength Set Menstrual Cup Steamer Pixie Pulse Replacement Gel Pads Pixie Pixie Cup Pixie Organic Cotton Tampons Pixie Cup Dot Cup

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2025-04-30
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-04-08
NUQ	Pad, Menstrual, Reusable	Obstetrics/Gynecology	Class 1	884.5435	2025-04-28
HER	Pelvimeter, External	Obstetrics/Gynecology	Class 1	884.4520	2025-08-12
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2021-08-19
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2026-01-08
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2024-06-13
HGD	Applicator, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2023-11-01
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	Class 2	884.5470	2026-05-21
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2019-10-16

Official Correspondent

Amber English

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PIXIE CUP LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28
K923985	Personal Products Co.	UNSCENTED MENSTRUAL TAMPON	1993-02-19
K151170	Tosama, D.O.O.	Tosama 100% Organic Cotton Menstrual Tampon	2015-07-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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2212018	PARKER LABORATORIES, INC.	FAIRFIELD, NJ, US
1043214	DEROYAL INDUSTRIES, INC.	POWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013865802. Last updated year: 2026. Please use registration number 3013865802 when referencing this establishment in official correspondence.