Cleared Traditional

K261616 - Single-Use EBUS Balloon

K261616 is an FDA 510(k) clearance for Single-Use EBUS Balloon, manufactured by Micro-Tech (Nanjing) Co., Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code PSV cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K261616 · Micro-Tech (Nanjing) Co., Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
153d
Days
Class 2
Risk

K261616 is an FDA 510(k) clearance for the Single-Use EBUS Balloon. Classified as Ultrasound Bronchoscope (product code PSV), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on October 15, 2026 after a review of 153 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 892.1550 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K261616

510(k) Number K261616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2026
Decision Date October 15, 2026
Days to Decision 153 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 90d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PSV Device Classification - Class 2, Special Controls

Product Code PSV Ultrasound Bronchoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
Definition An Ultrasound Bronchoscope Is Indicated For The Ultrasonic Visualization, Diagnosis And Therapeutic Access To The Bronchial Tree Or The Lungs. 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 - PSV Ultrasound Bronchoscope

Devices cleared under the same product code (PSV) and FDA review panel - the closest regulatory comparables to K261616.
EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
K260401 · Olympus Medical Systems Corporation · Aug 2026
EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
K183525 · Olympus Medical Systems Corp. · Sep 2019
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM
K070983 · Olympus Medical Systems Corporation · Jul 2007
OLYMPUS BF TYPE UM40
K021204 · Olympus Optical Co., Ltd. · May 2002
K261616 · Single-Use EBUS Balloon
Download PDF FDA Summary Micro-Tech (Nanjing) …