Cleared Traditional

K182049 - exCellerator Cervical Collection Device (FDA 510(k) Clearance)

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

K182049 · Excell Company, LLC · Pathology device
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.

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
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 223d · 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.