Cleared Traditional

K241322 - Electric Breast Pump (LD-208L

K241322 is the FDA 510(k) clearance for Electric Breast Pump (LD-208L by Joytech Healthcare Co. , Ltd.. It is a Class 2 Obstetrics & Gynecology device (product code HGX) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

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

K241322 is an FDA 510(k) clearance for the Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010). Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Joytech Healthcare Co. , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on December 19, 2024 after a review of 223 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5160 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Joytech Healthcare Co. , Ltd. devices

Submission Details

510(k) Number K241322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 160d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HGX Pump, Breast, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGX Pump, Breast, Powered

All 128
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K241322.
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K241004 · Huizhou Lvb Maternal and Infant Supplies Co., Ltd. · Sep 2024