Cleared Special

K230339 - EsoCheck Cell Collection Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230339 · Lucid Diagnostics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
17d
Days
Class 2
Risk

K230339 is an FDA 510(k) clearance for the EsoCheck 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 February 24, 2023 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 874.4710 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lucid Diagnostics, Inc. devices

Submission Details

510(k) Number K230339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 07, 2023
Decision Date February 24, 2023
Days to Decision 17 days
Submission Type Special
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
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Hogan Lovells US LLP
Kelliann Payne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K230339.
EndoSign® Cell collection device (ES-CYT-102)
K233142 · Cyted Limited · Jan 2024
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