Cleared Traditional

K153128 - Kolplast Cervical Sample Collection Kit

K153128 is an FDA 510(k) clearance for Kolplast Cervical Sample Collection Kit, manufactured by Kolplast CI SA. The device is a Class 2 Pathology device with product code HHT cleared through the Traditional 510(k) pathway after a 442-day FDA review.

K153128 · Kolplast CI SA · Pathology device
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Jan 2017
Decision
442d
Days
Class 2
Risk

K153128 is an FDA 510(k) clearance for the Kolplast Cervical Sample Collection Kit. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Kolplast CI SA (Itupeva- Sp, BR). The FDA issued a Cleared decision on January 13, 2017 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 884.4530 - the FDA pathology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

View all Kolplast CI SA devices

FDA 510(k) Submission Details - K153128

510(k) Number K153128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2015
Decision Date January 13, 2017
Days to Decision 442 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
364d slower than avg
Panel avg: 78d · This submission: 442d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHT Device Classification - Class 2, Special Controls

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 Pathology devices follow this clearance model.

Regulatory Consultant

Smith Assoicates
YOLANDA SMITH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HHT Spatula, Cervical, Cytological

All 37
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K153128.
exCellerator Cervical Collection Device
K182049 · Excell Company, LLC · Apr 2019
DISPOSABLE CERVICAL BRUSH
K141057 · Ningbo Hls Medical Products Co., Ltd. · May 2015
HISTOBRUSH
K111681 · Puritan Medical Products Company, LLC · Jan 2012
PAPCONE
K083012 · Otto Bock Pur Life Science GmbH · Apr 2009
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
K081522 · Bio Nuclear Diagnostics, Inc. · Dec 2008
SOFTPAP CERVICAL CELL COLLECTOR
K072381 · Cytocore, Inc. · Jan 2008