Cleared Traditional

K182049 - exCellerator Cervical Collection Device

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

K182049 · Excell Company, LLC · Pathology device
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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

Submission Details

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.

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 Pathology devices follow this clearance model.

Regulatory Peers - HHT Spatula, Cervical, Cytological

Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K182049.
DETECT CYTOLOGY BRUSH II
K960469 · Cook Urological, Inc. · Mar 1996
KOTEX SUPER MAXI PADS
K890013 · Kimberly-Clark Corp. · Apr 1989
ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG
K891032 · Zinnanti Surgical Instruments, Inc. · Mar 1989
ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH
K875162 · Ortho Diagnostic Systems, Inc. · Jan 1988
ORTHO* SPECIMEN COLLECTION CYTOBRUSH
K871552 · Ortho Diagnostic Systems, Inc. · Jun 1987
CYCLO-BRUSH
K870782 · Medline Industries, Inc. · May 1987