Cleared Traditional

OPERA, OPERA eco (K190810) - FDA 510(k) Clearance

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

K190810 · Unimom.Co · Obstetrics & Gynecology device
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Aug 2019
Decision
154d
Days
Class 2
Risk

K190810 is an FDA 510(k) clearance for the OPERA, OPERA eco. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Unimom.Co (Osan-Si, KR). The FDA issued a Cleared decision on August 30, 2019 after a review of 154 days - an extended review cycle.

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.

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Submission Details

510(k) Number K190810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2019
Decision Date August 30, 2019
Days to Decision 154 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
6d faster than avg
Panel avg: 160d · This submission: 154d
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 K190810.
Freestyle Flex
K191653 · Medela AG · Oct 2019
Spectra Cashmere
K191208 · Uzinmedicare Co. · Oct 2019
Willow Wearable Breast Pump 2.0
K191577 · Exploramed Nc7, Inc. · Sep 2019
Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump
K182749 · Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd. · Jun 2019
Electric Breast Pump
K182413 · Guangdong Horigen Mother & Baby Products Co., Ltd. · Mar 2019
Spectra S3 Plus
K181784 · Uzinmedicare Co. · Nov 2018