Double Up Breast Pump
by The Natural Choice Co., Inc.
510(k) K964396
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964396 | Date6 Jun 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HGX
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5160
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Double Up Breast Pump is a powered, double-channel electric breast pump designed to facilitate simultaneous milk expression from both breasts. It falls under the category of breast pumps, intended for use by lactating individuals to support breastfeeding or milk storage.
This device is supplied as a reusable, non-sterile medical instrument, intended for home or clinical use. It operates on electrical power and includes multiple suction settings to accommodate individual comfort and efficiency. Authorized under FDA 510(k) clearance (K964396) with a classification as Class II, it adheres to regulatory standards for obstetrics and gynecology applications. No MRI safety or single-use specifications are noted in the data.
Questions
AI-generated answers, 19 Sep 2026
Is the Double Up Breast Pump intended for single-use or can it be reused?
The Double Up Breast Pump is designed as a reusable device, not for single-use. It is explicitly labeled as a reusable, non-sterile medical instrument, suitable for both home and clinical environments. However, it is not sterile out of the box, so proper cleaning and maintenance are required before and after each use.
What types of suction settings does the Double Up Breast Pump offer, and how do they help?
The Double Up Breast Pump includes multiple suction settings, which allow users to adjust the intensity to match their comfort level and efficiency. This flexibility accommodates individual preferences, helping to optimize milk expression during breastfeeding or milk storage sessions.
How many models or variations of the Double Up Breast Pump are available, and are there specific size options?
The device data lists multiple registration numbers (e.g., 3012298445, 3024790242, etc.), which likely correspond to different models or variations of the Double Up Breast Pump. While specific size details (e.g., flange sizes) are not provided in the data, these variations may include differences in features, accessories, or compatibility with various breast shapes. For precise sizing, refer to the manufacturer’s documentation or contact The Natural Choice Co., Inc.
How should the Double Up Breast Pump be stored, and are there any special handling instructions?
Since the Double Up Breast Pump is reusable and non-sterile, it should be stored in a clean, dry environment to prevent contamination. The manufacturer likely provides specific cleaning and storage guidelines in the accompanying user manual. Proper maintenance, such as disinfection between uses in clinical settings, is essential to ensure hygiene and longevity of the device.
What is the regulatory pathway for the Double Up Breast Pump, and how does it relate to its use in clinical or home settings?
The Double Up Breast Pump is authorized under the FDA’s 510(k) clearance process, specifically with clearance number K964396, and classified as Class II. This pathway confirms it meets regulatory standards for obstetrics and gynecology applications. While the device is suitable for both home and clinical use, its regulatory status does not restrict its application—it simply ensures compliance with safety and performance requirements for breast pumps in these environments.