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510(k) K241322

Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) by Joytech Healthcare Co. , Ltd. — Product Code HGX

K241322 is an FDA 510(k) premarket notification submitted by Joytech Healthcare Co. , Ltd. for the device "Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)". The FDA issued a decision of Substantially Equivalent on December 19, 2024. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Joytech Healthcare Co. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2024
Date Received
May 10, 2024
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

Other clearances by Joytech Healthcare Co. , Ltd.

  • K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P, (August 13, 2026)
  • K252501 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, D (April 28, 2026)
  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (February 13, 2026)
  • K243468 — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebul (July 2, 2025)
  • K250548 — Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) (June 26, 2025)
  • K241431 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, D (January 13, 2025)
  • K231303 — Arm-type Fully Automatic Digital Blood Pressure Monitor (January 26, 2024)
  • K230566 — Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automa (August 25, 2023)
  • K213189 — Wrist-type Fully Automatic Digital Blood Pressure Monitor (March 1, 2022)
  • K212115 — Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automa (January 5, 2022)

Other clearances for product code HGX

  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (July 24, 2026)
  • 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)

FDA data resources