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510(k) K100385

NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP by Luv N' Care, Ltd. — Product Code HGX

K100385 is an FDA 510(k) premarket notification submitted by Luv N' Care, Ltd. for the device "NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP". The FDA issued a decision of Substantially Equivalent on Mar 24, 2010. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Luv N' Care, Ltd. has 1 other 510(k) clearance on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 24, 2010
Date Received
Feb 16, 2010
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
510(k)

Other clearances by Luv N' Care, Ltd.

  • K092494 — GEL FILLED GUM SOOTHER (Mar 1, 2010)

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 K100385. Report a data issue: hello@regdatalab.com.