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510(k) K052909

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

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

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  • K252422 — Wearable Breast Pump (Model W2) (February 13, 2026)
  • K253149 — Motion InBra (YM-8801) wearable breast pump (February 13, 2026)
  • K252420 — Wearable Breast Pump (Model W12) (February 13, 2026)
  • K251423 — Spectra S1 Pro; Spectra S2 Pro (February 6, 2026)
  • K253498 — Pump In Style® Pro+ (January 22, 2026)
  • K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 P (December 23, 2025)
  • K252342 — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) (December 19, 2025)
  • K252754 — Wearable Electric Breast Pump (YM-8803) (December 19, 2025)