Cleared Special

K252528 - Ion Endoluminal System (IF1000)

K252528 is an FDA 510(k) clearance for Ion Endoluminal System (IF1000), manufactured by Intuitive Surgical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Special 510(k) pathway after a 25-day FDA review.

K252528 · Intuitive Surgical, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
25d
Days
Class 2
Risk

K252528 is an FDA 510(k) clearance for the Ion Endoluminal System (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 September 5, 2025 after a review of 25 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. 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.

FDA 510(k) Submission Details - K252528

510(k) Number K252528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2025
Decision Date September 05, 2025
Days to Decision 25 days
Submission Type Special
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
65d faster than avg
Panel avg: 90d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 243
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K252528.
KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)
K251731 · Karl Storz SE & CO. KG · Dec 2025
Himaging Bronchscope System
K251894 · Himaging Technology (Shanghai) Co., Ltd. · Sep 2025
Ion Endoluminal System (IF1000)
K252045 · Intuitive Surgical, Inc. · Sep 2025
Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
K251752 · Shanghai AnQing Medical Instrument Co., Ltd. · Aug 2025
UE BRONCHO Single-Use Bronchoscopes (EBS-380C)
K251823 · Zhejiang UE Medical Corp. · Aug 2025
Vathin® Video Bronchoscope System
K250232 · Hunan Vathin Medical Instrument Co., Ltd. · Jul 2025
K252528 · Ion Endoluminal System (IF1000)
Download PDF FDA Summary Intuitive Surgical, I…