Cleared Traditional

K162870 - CIMLRE F1 and CIMILRE S3

K162870 is an FDA 510(k) clearance for CIMLRE F1 and CIMILRE S3, manufactured by Cimilre Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGX cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K162870 · Cimilre Co., Ltd. · Obstetrics & Gynecology device
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Mar 2017
Decision
145d
Days
Class 2
Risk

K162870 is an FDA 510(k) clearance for the CIMLRE F1 and CIMILRE S3. Classified as Pump, Breast, Powered (product code HGX), Class II - Special Controls.

Submitted by Cimilre Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on March 7, 2017 after a review of 145 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 Cimilre Co., Ltd. devices

FDA 510(k) Submission Details - K162870

510(k) Number K162870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2016
Decision Date March 07, 2017
Days to Decision 145 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
16d faster than avg
Panel avg: 161d · This submission: 145d
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 227
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