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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 161d · 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 238
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K122474.
EVENFLO ADVANCED DOUBLE ELECTRIC BREAST PUMP
K131153 · Evenflo Feeding Incorporated · Jun 2013
MEMORY PUMP MODEL Y4947
K131027 · Tomy International · May 2013
NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP
K121478 · Mapa GmbH · Apr 2013
RUMBLE TUFF
K113315 · Acute Ideas Co. , Ltd. · Nov 2012
CLOSER TO NATURE
K121322 · Mayborn Group Limited · May 2012
LUCINA-MELODI
K112856 · Genadyne Biotechnologies, Inc. · May 2012
K122474 · LANSINOH POWERED ELECTRIC BREAST PUMP
Download PDF FDA Summary Lansinoh Laboratories…