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510(k) K052909

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

K052909 is an FDA 510(k) premarket notification submitted by Evenflo Company, Inc. for the device "EVENFLO ELAN BREAST PUMP". The FDA issued a decision of Substantially Equivalent on November 1, 2005. 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
November 1, 2005
Date Received
October 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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.

  • K102600 — SIMPLYGO BREAST PUMP (December 22, 2010)
  • 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)
  • 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