Cleared Traditional

K141057 - DISPOSABLE CERVICAL BRUSH (FDA 510(k) Clearance)

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

K141057 · Ningbo Hls Medical Products Co., Ltd. · Obstetrics & Gynecology device
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May 2015
Decision
385d
Days
Class 2
Risk

K141057 is an FDA 510(k) clearance for the DISPOSABLE CERVICAL BRUSH. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Ningbo Hls Medical Products Co., Ltd. (Dover, US). The FDA issued a Cleared decision on May 14, 2015 after a review of 385 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.

View all Ningbo Hls Medical Products Co., Ltd. devices

Submission Details

510(k) Number K141057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2014
Decision Date May 14, 2015
Days to Decision 385 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
225d slower than avg
Panel avg: 160d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HHT Spatula, Cervical, Cytological
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.