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
Regulatory Context
Review time vs. panel average
365d slower than avg
Panel avg: 77d · 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 Peers - HHT Spatula, Cervical, Cytological

All 12
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
DETECT CYTOLOGY BRUSH II
K960469 · Cook Urological, Inc. · Mar 1996
DETECT (TM) CYTOLOGY BRUSH
K933415 · Cook Ob/Gyn · Feb 1994
SPATULA FOR PAP SMEAR COLLECTION
K893229 · Medical Device Inspection Co., Inc. · Feb 1990
KOTEX SUPER MAXI PADS
K890013 · Kimberly-Clark Corp. · Apr 1989
ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG
K891032 · Zinnanti Surgical Instruments, Inc. · Mar 1989