Cleared Traditional

K162415 - Spectra 9Plus

K162415 is an FDA 510(k) clearance for Spectra 9Plus, manufactured by Uzinmedicare Company. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K162415 · Uzinmedicare Company · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
198d
Days
Class 2
Risk

K162415 is an FDA 510(k) clearance for the Spectra 9Plus. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Uzinmedicare Company (Seoul, KR). The FDA issued a Cleared decision on March 15, 2017 after a review of 198 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.

FDA 510(k) Submission Details - K162415

510(k) Number K162415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2016
Decision Date March 15, 2017
Days to Decision 198 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 161d · This submission: 198d
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 K162415.
Yooeehouse Breast Pump
K163183 · Nantong Poly Technology Co., Ltd. · Oct 2017
Moxxly Flow Collection System
K170722 · Moxxly, Inc. · Aug 2017
Youha electric breast pump
K163136 · Ningbo Youhe Electrical Appliance Technology Co., Ltd. · Jul 2017
CIMLRE F1 and CIMILRE S3
K162870 · Cimilre Co., Ltd. · Mar 2017
Proture Double Electric Breast Pump
K162747 · Guangdong Horigen Mother & Baby Products Co., Ltd. · Dec 2016
Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
K161725 · Medela, Inc. · Oct 2016
K162415 · Spectra 9Plus
Download PDF FDA Summary Uzinmedicare Company