Cleared Special

K122474 - LANSINOH POWERED ELECTRIC BREAST PUMP

K122474 is an FDA 510(k) clearance for LANSINOH POWERED ELECTRIC BREAST PUMP, manufactured by Lansinoh Laboratories Saglik Gerecleri Tasarim San. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Special 510(k) pathway after a 136-day FDA review.

K122474 · Lansinoh Laboratories Saglik Gerecleri Tasarim San · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
136d
Days
Class 2
Risk

K122474 is an FDA 510(k) clearance for the LANSINOH POWERED ELECTRIC BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Lansinoh Laboratories Saglik Gerecleri Tasarim San (Westminster, US). The FDA issued a Cleared decision on December 28, 2012 after a review of 136 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lansinoh Laboratories Saglik Gerecleri Tasarim San devices

FDA 510(k) Submission Details - K122474

510(k) Number K122474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2012
Decision Date December 28, 2012
Days to Decision 136 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 160d · This submission: 136d
Pathway characteristics
Modification to existing cleared device.

HGX Device Classification - Class 2, Special Controls

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 150
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