Cleared Special

K250210 - Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) (FDA 510(k) Clearance)

Also includes:
Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250210 · Scivita Medical Technology Co., Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
54d
Days
Class 2
Risk

K250210 is an FDA 510(k) clearance for the Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P.... Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Scivita Medical Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on March 19, 2025 after a review of 54 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.

View all Scivita Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K250210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2025
Decision Date March 19, 2025
Days to Decision 54 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
35d faster than avg
Panel avg: 89d · This submission: 54d
Pathway characteristics
Modification to existing cleared device.

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 236
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K250210.
EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190)
K252341 · Olympus Medical Systems Corp. · Apr 2026
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
K260420 · MacroLux Medical Technology Co., Ltd. · Apr 2026
FUJIFILM Ultrasonic Endoscope EB-710US
K250863 · Fujifilm Corporation · Dec 2025
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