FDA product code PWA: Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure
PWA is the FDA product code for breast pump accessory, milk expression aid, via positive pressure. It is a Class I device, regulated under 21 CFR 884.5150 and reviewed by the Obstetrics and Gynecology panel. Devices under PWA reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Designed to be used in conjunction with powered or non-powered breast pumps to apply positive pressure to the breast to aid in milk expression from the breasts of a nursing woman.
Classification
| Field | Value |
|---|---|
| Device name | Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure |
| Device class | Class I |
| Regulation | 21 CFR 884.5150 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for PWA devices
openFDA lists no recalls for product code PWA.
Frequently asked questions
What is FDA product code PWA?
PWA is the FDA product code for breast pump accessory, milk expression aid, via positive pressure. It is a Class I device, regulated under 21 CFR 884.5150 and reviewed by the Obstetrics and Gynecology panel.
What device class is PWA?
Class I, regulation 21 CFR 884.5150. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PWA
- Run a recall and safety report across every PWA manufacturer
- Watch product code PWA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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