Cleared Traditional

K182049 - exCellerator Cervical Collection Device

K182049 is an FDA 510(k) clearance for exCellerator Cervical Collection Device, manufactured by Excell Company, LLC. The device is a Class 2 Pathology device with product code HHT cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K182049 · Excell Company, LLC · Pathology device
Download Printable Device Report (PDF)
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Apr 2019
Decision
268d
Days
Class 2
Risk

K182049 is an FDA 510(k) clearance for the exCellerator Cervical Collection Device. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Excell Company, LLC (Carmel, US). The FDA issued a Cleared decision on April 25, 2019 after a review of 268 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Excell Company, LLC devices

FDA 510(k) Submission Details - K182049

510(k) Number K182049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2018
Decision Date April 25, 2019
Days to Decision 268 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
191d slower than avg
Panel avg: 77d · This submission: 268d
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 26
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K182049.
HISTOBRUSH
K111681 · Puritan Medical Products Company, LLC · Jan 2012
ORIBRUSH - STANDARD - B002
K991593 · Orifice Medical AB · Jun 1999
ORIBRUSH - WITH PROTECTIVE TIP - B001
K991595 · Orifice Medical AB · Jun 1999
HARWILL MEDICAL CERVITULA CERVICAL SPATULA
K983202 · Harwill Medical (Pty) , Ltd. · Mar 1999
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K983599 · Andwin Scientific · Dec 1998
SAFETEX CERVICAL SCRAPER (PLASTIC)
K983428 · Andwin Scientific · Nov 1998