Cleared Traditional

BRANDT ESOPHAGEAL CYTOLOGY BALLOON (K911588) - FDA 510(k) Clearance

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

K911588 · Wilson-Cook Medical, Inc. · Ear, Nose, Throat device
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Nov 1992
Decision
589d
Days
Class 2
Risk

K911588 is an FDA 510(k) clearance for the BRANDT ESOPHAGEAL CYTOLOGY BALLOON. Classified as Esophagoscope (flexible Or Rigid) (product code EOX), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on November 18, 1992 after a review of 589 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

View all Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number K911588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1991
Decision Date November 18, 1992
Days to Decision 589 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
500d slower than avg
Panel avg: 89d · This submission: 589d
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 K911588.
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