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510(k) K102600

SIMPLYGO BREAST PUMP by Evenflo Company, Inc. — Product Code HGX

K102600 is an FDA 510(k) premarket notification submitted by Evenflo Company, Inc. for the device "SIMPLYGO BREAST PUMP". The FDA issued a decision of Substantially Equivalent on December 22, 2010. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Evenflo Company, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2010
Date Received
September 10, 2010
Clearance Type
Special
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 by Evenflo Company, Inc.

  • K100435 — AMEDA PLATINUM BREAST PUMP (May 28, 2010)
  • K092770 — SIMPLYGO HANDS FREE BREAST PUMP (October 9, 2009)
  • K082307 — EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT (September 11, 2008)
  • K053493 — BERRY FRUITY TEETHER (February 22, 2006)
  • K052909 — EVENFLO ELAN BREAST PUMP (November 1, 2005)
  • K022933 — EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT (December 2, 2002)
  • K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (December 20, 2001)

Other clearances for product code HGX

  • 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)
  • K260538 — Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (June 17, 2026)
  • K260346 — Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H11 (June 12, 2026)
  • K250129 — AViTA Breast Pump (June 11, 2026)
  • K260864 — Mother's Nature W1 Warming Wearable Breast Pump (June 9, 2026)
  • K260956 — Spectra Platinum Mini (June 4, 2026)
  • K254300 — eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T600 (May 29, 2026)

FDA data resources