510(k) K942534

GERBER NATURAL COMFORT BATTERY BREAST PUMP by Gerber Products Co. — Product Code HGX

K942534 is an FDA 510(k) premarket notification submitted by Gerber Products Co. for the device "GERBER NATURAL COMFORT BATTERY BREAST PUMP". The FDA issued a decision of Substantially Equivalent on May 25, 1995. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Gerber Products Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 25, 1995
Date Received: May 27, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Pump, Breast, Powered
Device Class: Class II
Regulation Number: 884.5160
Review Panel: OB
Submission Type

Other clearances for product code HGX

K254203 — Wearable Breast Pump (Model S36) (September 17, 2026)
K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF5 (September 3, 2026)
K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (September 1, 2026)
K260643 — Cimilre Dual Max (August 21, 2026)
K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (August 20, 2026)
K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3) (July 24, 2026)
K261199 — Wearable Breast Pump (Model S32A) (July 13, 2026)
K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (June 25, 2026)
K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (June 18, 2026)

510(k) K942534

Clearance Details

Device Classification

Other clearances by Gerber Products Co.

Other clearances for product code HGX

FDA data resources