Cleared Traditional

EsoCheck CCD Cell Collection Device (K183262) - FDA 510(k) Clearance

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

K183262 · Lucid Diagnostics, Inc. · Gastroenterology & Urology device
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Jun 2019
Decision
210d
Days
Class 2
Risk

K183262 is an FDA 510(k) clearance for the EsoCheck CCD Cell Collection Device. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by Lucid Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on June 21, 2019 after a review of 210 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 874.4710 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lucid Diagnostics, Inc. devices

Submission Details

510(k) Number K183262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 23, 2018
Decision Date June 21, 2019
Days to Decision 210 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 130d · This submission: 210d
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EOX Esophagoscope (flexible Or Rigid)

All 17
Devices cleared under the same product code (EOX) and FDA review panel - the closest regulatory comparables to K183262.
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
K203450 · Capnostics, LLC · May 2021
EsoCheck Cell Collection Device
K210137 · Lucid Diagnostics, Inc. · Feb 2021
CMOS Video Esophagoscope SSU
K192523 · Karl Storz SE & CO. KG · Jan 2020
Strome-Blitzer Cytology Balloon
K182159 · Adn International, LLC · Jun 2019
PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
K181292 · Cogentix Medical, Inc. · Nov 2018
Cytosponge Cell Collection Device
K181020 · Covidien, LLC · Aug 2018