Annabella Double Breast Pump (ADO-US23-1000)
510(k) K241506
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241506 | Date27 Jun 2024 | 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- Withdrawn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, 20 Sep 2026
The Annabella Double Breast Pump (ADO-US23-1000) is a Powered, Breast Pump designed to assist lactating individuals in expressing milk from both breasts simultaneously. This device mimics a natural suckling pattern to encourage milk production and includes a closed-system design to maintain hygiene by preventing milk from entering the tubing or motor.
This device is intended for home use and is supplied as a reusable, non-sterile medical product. It operates on electrical power and is compatible with breast milk storage bags. The pump is classified as Class II under FDA regulations, with a 510(k) clearance (K241506) for obstetrics/gynecology applications. No MRI safety information is specified, and sizes (18–24mm or 25–28mm) are determined by flange compatibility.
Other devices from Annabella Tech
Questions
AI-generated answers, 20 Sep 2026
Is the Annabella Double Breast Pump designed for single-use or can it be reused over time?
The Annabella Double Breast Pump (ADO-US23-1000) is explicitly supplied as a reusable device, not intended for single-use. It is classified as a non-sterile medical product for home use, meaning it is meant to be cleaned and reused by the same user over time, provided proper maintenance is followed.
What flange sizes are compatible with the Annabella Double Breast Pump, and how do I determine the right fit?
The Annabella Double Breast Pump accommodates flange sizes of 18–24mm or 25–28mm, depending on flange compatibility. The correct size is determined by the user’s nipple size and comfort—most users find the right fit by trying different sizes or consulting manufacturer guidelines for proper flange selection to ensure effective milk expression.
How is the Annabella Double Breast Pump powered, and what accessories are included for milk storage?
The Annabella Double Breast Pump is powered by electricity, requiring a power source for operation. It is designed to be used with breast milk storage bags, which are compatible accessories for collecting and storing expressed milk after pumping.
What hygiene features does the Annabella Double Breast Pump include to prevent contamination?
The pump features a closed-system design, which prevents milk from entering the tubing or motor, reducing the risk of contamination. This design helps maintain hygiene during use, though users should still follow cleaning instructions for reusable parts to ensure optimal safety and performance.
How was the regulatory approval for this device determined, and what does that mean for its use?
The Annabella Double Breast Pump received FDA 510(k) clearance (K241506) under the Obstetrics/Gynecology advisory committee, with a determination of Substantially Equivalent (SE) to a predicate device. This means the FDA reviewed it as a Class II medical device and found it to meet safety and effectiveness standards for home use in lactating individuals, though it does not imply any specific clinical indication beyond its intended purpose.