ISIS IQ UNO Handheld Electronic Breast Pump, Model 101
by Avent America, Inc. 510(k)
Active
510(k) K052047
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052047 | Date22 Sep 2005 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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 ISIS IQ UNO Handheld Electronic Breast Pump, Model 101, is a powered breast pump designed for manual milk expression and collection from lactating women. It operates using a vacuum pump, 6V DC motor, and microprocessor-controlled hand controller to adjust vacuum frequency and levels, facilitating efficient milk extraction.
This device is intended for single-use or reusable applications in home or clinical settings, depending on usage. Supplied as a portable unit, it requires no sterilisation for home use but may be cleaned and disinfected for reusable clinical applications. The pump is classified as a Class II medical device under FDA regulations (K052047, 884.5160) and has received FDA 510K clearance through the Traditional pathway, with advisory review by the Obstetrics/Gynecology Committee.
Other devices from Avent America, Inc.
Questions
AI-generated answers, 20 Sep 2026
Can this breast pump be used in both home and clinical settings, and what cleaning requirements apply in each?
Yes, the ISIS IQ UNO Handheld Electronic Breast Pump (Model 101) is designed for use in both home and clinical settings. For home use, no sterilization is required, but standard cleaning is necessary to maintain hygiene. In clinical settings, the pump may be cleaned and disinfected for reusable applications, though the device itself is not pre-sterilized.
How does the ISIS IQ UNO Handheld Electronic Breast Pump adjust vacuum levels, and what makes it suitable for different users?
The ISIS IQ UNO uses a microprocessor-controlled hand controller to adjust vacuum frequency and levels, allowing users to customize settings for comfort and efficiency. This adaptability makes it suitable for a range of users, accommodating varying preferences for milk extraction intensity.
What regulatory pathway was followed for FDA clearance of this device, and which committee reviewed it?
The ISIS IQ UNO Handheld Electronic Breast Pump received FDA 510K clearance through the Traditional pathway, with an advisory review conducted by the Obstetrics/Gynecology Committee. This pathway confirms the device is substantially equivalent to a legally marketed predicate.
Are there multiple sizes or models of this breast pump, and how would I identify the correct one for my needs?
The device data lists multiple registration numbers (e.g., 3012298445, 3024790242) associated with the ISIS IQ UNO Handheld Electronic Breast Pump, which may indicate variations in accessories or configurations rather than distinct physical sizes. The core unit (Model 101) is portable and handheld, so compatibility depends on the included components or accessories. Always verify the exact model and accessories with the manufacturer to ensure it meets your specific requirements.