Cleared Traditional

Smartpump 3.0 Double Electric Breast Pump (K222726) - FDA 510(k) Clearance

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

K222726 · Lansinoh Laboratories · Obstetrics & Gynecology device
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Dec 2022
Decision
106d
Days
Class 2
Risk

K222726 is an FDA 510(k) clearance for the Smartpump 3.0 Double Electric Breast Pump. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Lansinoh Laboratories (Alexandria, US). The FDA issued a Cleared decision on December 23, 2022 after a review of 106 days - within the typical 510(k) review window.

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 Lansinoh Laboratories devices

Submission Details

510(k) Number K222726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2022
Decision Date December 23, 2022
Days to Decision 106 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
54d faster than avg
Panel avg: 160d · This submission: 106d
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 127
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K222726.
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199
K222782 · Zhejiang Carebao Co., Ltd. · Jan 2023
Wearable Breast Pump (Model S1DW)
K222045 · Shenzhen TPH Technology Co., Ltd. · Jan 2023
CIMILRE Free-T2 Plus
K221708 · Cimilre Co., Ltd. · Dec 2022
Spectra Wearable
K220926 · Uzinmedicare Co., Ltd. · Dec 2022
Wearable breast pump
K221598 · Mayborn (Uk) Limited · Dec 2022
Ameda Pearl Electric Breast Pump
K221576 · Ameda, Inc. · Oct 2022