Cleared Traditional

K151632 - Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental

K151632 is an FDA 510(k) clearance for Symphony Breastpump, manufactured by Medela AG. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K151632 · Medela AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
141d
Days
Class 2
Risk

K151632 is an FDA 510(k) clearance for the Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Sy.... Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Medela AG (Baar, CH). The FDA issued a Cleared decision on November 5, 2015 after a review of 141 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 Medela AG devices

FDA 510(k) Submission Details - K151632

510(k) Number K151632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2015
Decision Date November 05, 2015
Days to Decision 141 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
19d faster than avg
Panel avg: 160d · This submission: 141d
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 Consultant

Pathway Regulatory Consulting, LLC
ADRIENNE LENZ

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HGX Pump, Breast, Powered

All 202
Devices cleared under the same product code (HGX) and FDA review panel - the closest regulatory comparables to K151632.
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