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Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure

Page Type
Product Code
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.
Physical State
External device that provides positive pressure to a woman’s breast.
Technical Method
Provide low, positive pressure to the breast to aid in expression of milk in conjunction with a powered or non-powered breast pump.
Target Area
Breast
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
884.5150
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5150 Nonpowered breast pump

§ 884.5150 Nonpowered breast pump.

(a) Identification. A nonpowered breast pump is a manual suction device used to express milk from the breast.

(b) Classification. 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.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001]

Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure

Page Type
Product Code
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.
Physical State
External device that provides positive pressure to a woman’s breast.
Technical Method
Provide low, positive pressure to the breast to aid in expression of milk in conjunction with a powered or non-powered breast pump.
Target Area
Breast
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
884.5150
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5150 Nonpowered breast pump

§ 884.5150 Nonpowered breast pump.

(a) Identification. A nonpowered breast pump is a manual suction device used to express milk from the breast.

(b) Classification. 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.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001]