# K051413: Isis IQ Duo Twin Electronic Breast Pump, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Avent America, Inc.
- Decided: Aug 29, 2005 after 90 days
- Product code: HGX (Pump, Breast, Powered)
- Device class: 2
- Regulation: 21 CFR 884.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K801862 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031614: Medela Pump in Style Advanced Breast Pump, Medela, Inc. (2003) Summary page 1.

## Indications for use
The ISIS iQ DUO Twin Electronic Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

Source page: https://510kreport.com/device/K051413
Methodology: https://510kreport.com/methodology