# K101538: Handheld Manual Breast Pump (Avent Manual Breast Pump)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Electronics UK Limited
- Decided: Nov 5, 2010 after 155 days
- Product code: HGY (Pump, Breast, Non-Powered)
- Device class: 1
- Regulation: 21 CFR 884.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K801862 (1980). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K823591: Ameda Hand Breast Pump, Burditt & Calkins-Siemens-Elema (1982) Summary page 1.
- K052047: Isis IQ Uno Handheld Electronic Breast Pump, Model 101, Avent America, Inc. (2005) Summary page 1.
- K823840: Medela Namual Breast Pump, Medela, Inc. (1983). Our reading of the summary gave K828340, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped in this product code whose FDA name shares the summary’s words.

## Indications for use
The Philips Avent Manual Breast Pump is intended to express and collect milk from the breasts of a lactating woman.

Source page: https://510kreport.com/device/K101538
Methodology: https://510kreport.com/methodology