Cleared Traditional

K260420 - LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) (FDA 510(k) Clearance)

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

K260420 · MacroLux Medical Technology Co., Ltd. · Ear, Nose, Throat device

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Apr 2026

Decision

58d

Days

Class 2

Risk

K260420 is an FDA 510(k) clearance for the LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG). Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by MacroLux Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 8, 2026 after a review of 58 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 MacroLux Medical Technology Co., Ltd. devices

Submission Details

510(k) Number	K260420 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 2026
Decision Date	April 08, 2026
Days to Decision	58 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

31d faster than avg

Panel avg: 89d · This submission: 58d

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.