Cleared Traditional

K152794 - Cytosponge Cell Collection Device (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152794 · Covidien, LLC · Ear, Nose, Throat device
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Apr 2016
Decision
197d
Days
Class 2
Risk

K152794 is an FDA 510(k) clearance for the Cytosponge Cell Collection Device. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by Covidien, LLC (Mansfield, US). The FDA issued a Cleared decision on April 12, 2016 after a review of 197 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4710 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Covidien, LLC devices

Submission Details

510(k) Number K152794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2015
Decision Date April 12, 2016
Days to Decision 197 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 89d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOX Esophagoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4710
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOX Esophagoscope (flexible Or Rigid)

All 29
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K152794.
EndoSign® Cell collection device (ES-CYT-102)
K233142 · Cyted Limited · Jan 2024
EsoCheck Cell Collection Device
K230339 · Lucid Diagnostics, Inc. · Feb 2023
PENTAX Medical Video Esophagoscope EE17-J10
K223072 · Pentax of America, Inc. · Dec 2022
EsoCheck Cell Collection Device
K222366 · Lucid Diagnostics, Inc. · Oct 2022
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
K203450 · Capnostics, LLC · May 2021
EsoCheck Cell Collection Device
K210137 · Lucid Diagnostics, Inc. · Feb 2021