Cleared Traditional

K241322 - Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.