Cleared Traditional

K240135 - Ion Endoluminal System (Ion Fully Artic...

K240135 is the FDA 510(k) clearance for Ion Endoluminal System (Ion Fully Artic... by Intuitive Surgical, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K240135 · Intuitive Surgical, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Apr 2024
Decision
76d
Days
Class 2
Risk

K240135 is an FDA 510(k) clearance for the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000). Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 3, 2024 after a review of 76 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intuitive Surgical, Inc. devices

Submission Details

510(k) Number K240135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2024
Decision Date April 03, 2024
Days to Decision 76 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 89d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 176
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K240135.
MiiS Horus Bronchoscope
K234113 · Medimaging Integrated Solution, Inc (Miis) · May 2024
BioStar Single Use Transbronchial Aspiration Needle
K232038 · Broncus Medical, Inc. · Apr 2024
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
K233779 · MacroLux Medical Technology Co., Ltd. · Apr 2024
Bronchoscope System
K231107 · Hunan Endoso Life Technology Co., Ltd. · Feb 2024
FUJIFILM Endoscope Model EB-710XT
K240075 · Fujifilm Healthcare Americas Corporation · Feb 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
K232860 · Pentax of America, Inc. · Jan 2024