Cleared Traditional

Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)

K241322 · Joytech Healthcare Co. , Ltd. · Obstetrics & Gynecology
Dec 2024
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K241322 is an FDA 510(k) clearance for the Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010), a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Joytech Healthcare Co. , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 19, 2024, 223 days after receiving the submission on May 10, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K241322 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2024
Decision Date December 19, 2024
Days to Decision 223 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGX — Pump, Breast, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5160

Similar Devices — HGX Pump, Breast, Powered

All 226
Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)
K252583 · A Cute Baby, Inc. · Mar 2026
Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
K253934 · Shenzhen Root Innovation Technology Co., Ltd. · Mar 2026
Wearable Breast Pump (Model W12)
K252420 · Shenzhen TPH Technology Co., Ltd. · Feb 2026
Wearable Breast Pump (Model W2)
K252422 · Shenzhen TPH Technology Co., Ltd. · Feb 2026
Motion InBra (YM-8801) wearable breast pump
K253149 · Medela, LLC · Feb 2026
Spectra S1 Pro; Spectra S2 Pro
K251423 · Uzinmedicare Co., Ltd. · Feb 2026

More from Joytech Healthcare Co. , Ltd.

View all
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
K252685 · DXN · Feb 2026
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
K243468 · CAF · Jul 2025
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
K250548 · DXN · Jun 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)
K241431 · DXN · Jan 2025
Arm-type Fully Automatic Digital Blood Pressure Monitor
K231303 · DXN · Jan 2024