Cleared Abbreviated

K024165 - DUAL-LUMEN CATHETER

K024165 is an FDA 510(k) clearance for DUAL-LUMEN CATHETER, manufactured by Bistech, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Abbreviated 510(k) pathway after a 24-day FDA review.

K024165 · Bistech, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Jan 2003
Decision
24d
Days
Class 2
Risk

K024165 is an FDA 510(k) clearance for the DUAL-LUMEN CATHETER. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Bistech, Inc. (Ayer, US). The FDA issued a Cleared decision on January 10, 2003 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Bistech, Inc. devices

FDA 510(k) Submission Details - K024165

510(k) Number K024165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2002
Decision Date January 10, 2003
Days to Decision 24 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 89d · This submission: 24d
Pathway characteristics
Standards-based clearance path.

EOQ Device Classification - Class 2, Special Controls

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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 - EOQ Bronchoscope (flexible Or Rigid)

All 188
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K024165.
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
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K040018 · Boston Scientific Corp · Jan 2004
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K031966 · Cook, Inc. · Oct 2003
EB-1830T3, VIDEO BRONCHOSCOPE
K023376 · Pentax Precision Instrument Corp. · Oct 2002
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
K021344 · Vision-Sciences, Inc. · May 2002
MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
K984157 · Wilson-Cook Medical, Inc. · Dec 1998