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510(k) K960726

EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP by Evenflo Co., Inc. — Product Code HGX

K960726 is an FDA 510(k) premarket notification submitted by Evenflo Co., Inc. for the device "EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP". The FDA issued a decision of Substantially Equivalent on Jul 22, 1996. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Evenflo Co., Inc. has 2 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 22, 1996
Date Received
Feb 22, 1996
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
510(k)

Other clearances by Evenflo Co., Inc.

  • K983776 — EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP (Apr 26, 1999)
  • K960727 — EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT (Feb 14, 1997)

Other clearances for product code HGX

  • K261782 — MODO DUO Electric Pump (B11621, B11673) (Oct 16, 2026)
  • K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model… (Sep 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (Sep 1, 2026)
  • K260643 — Cimilre Dual Max (Aug 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (Aug 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (Jul 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (Jul 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (Jun 25, 2026)

FDA data resources

Source: FDA 510(k) database entry for K960726. Report a data issue: hello@regdatalab.com.