Cleared Traditional

K152350 - Regular and Special Umbilical Cord Clamp and Cutter (FDA 510(k) Clearance)

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

K152350 · Ningbo Feite Medical Device Co., Ltd. · Obstetrics & Gynecology device
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Jun 2016
Decision
313d
Days
Class 2
Risk

K152350 is an FDA 510(k) clearance for the Regular and Special Umbilical Cord Clamp and Cutter. Classified as Clamp And Cutter, Umbilical (product code NBZ), Class II - Special Controls.

Submitted by Ningbo Feite Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on June 28, 2016 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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. Elevated predicate reliance profile. 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 K152350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2015
Decision Date June 28, 2016
Days to Decision 313 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
153d slower than avg
Panel avg: 160d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBZ Clamp And Cutter, Umbilical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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.