Cleared Traditional

K901344 - MEDELA BATTERY OPERATED BREAST PUMP

K901344 is an FDA 510(k) clearance for MEDELA BATTERY OPERATED BREAST PUMP, manufactured by Medela, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K901344 · Medela, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
137d
Days
Class 2
Risk

K901344 is an FDA 510(k) clearance for the MEDELA BATTERY OPERATED BREAST PUMP. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Medela, Inc. (Chicago, US). The FDA issued a Cleared decision on August 6, 1990 after a review of 137 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.

FDA 510(k) Submission Details - K901344

510(k) Number K901344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1990
Decision Date August 06, 1990
Days to Decision 137 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 161d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 237
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K901344.
SINGLE HANDED BREAST PUMP
K941112 · Macneil Baby Care , Ltd. · Jan 1995
DELUXE MAGMAG BREAST PUMP
K936309 · Pigeon Corp. · Nov 1994
ADVANCED MAGMAG AC/BATTERY BREAST PUMP
K935249 · Pigeon Corp. · Nov 1994
FRANK MILK PUMP
K895114 · Buttner-Frank GmbH · Mar 1990
IVEX MODEL NO. BP 3000 BREASTPUMP
K893545 · Ivex Medical, Inc. · Feb 1990
MEDELA BREAST-PUMP LACTINA
K875300 · Medela, Inc. · Apr 1988
K901344 · MEDELA BATTERY OPERATED BREAST PUMP
Download PDF Medela, Inc.