21 CFR 884.5150 — Pump, Breast, Non-Powered
Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5150
Identification
A nonpowered breast pump is a manual suction device used to express milk from the breast.
Classification Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9, if the device is using either a bulb or telescoping mechanism which does not develop more than 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce cytotoxicity, irritation, or sensitization effects.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HGY | Pump, Breast, Non-Powered | 1 | 27 | |
| PWA | Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | 1 | 0 |
