Cleared Traditional

Pump In Style (K200508) - FDA 510(k) Clearance

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

K200508 · Medela, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
105d
Days
Class 2
Risk

K200508 is an FDA 510(k) clearance for the Pump In Style. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Medela, LLC (Mchenry, US). The FDA issued a Cleared decision on June 15, 2020 after a review of 105 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, LLC devices

Submission Details

510(k) Number K200508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date June 15, 2020
Days to Decision 105 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
55d faster than avg
Panel avg: 160d · This submission: 105d
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 K200508.
Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
K203383 · Philips Consumer Lifestyle - Innovation Site Eindhoven · Dec 2020
Philips Avent Single/Double electric breast pump Advanced
K201381 · Philips Consumer Lifestyle - Innovation Site Eindhoven · Oct 2020
Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
K193449 · Guangdong Horigen Mother & Baby Products Co., Ltd. · Sep 2020
Rumble Tuff Electric Breast Pump
K200712 · A Cute Baby, Inc. · Apr 2020
Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
K192640 · Guangzhou Yongyi Industrial Co., Ltd. · Mar 2020
Evolve Breast Pump
K200406 · Hygeia II Medical Group, Inc. · Mar 2020