Cleared Traditional

K232038 - BioStar Single Use Transbronchial Aspiration Needle (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232038 · Broncus Medical, Inc. · Anesthesiology device
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Apr 2024
Decision
291d
Days
Class 2
Risk

K232038 is an FDA 510(k) clearance for the BioStar Single Use Transbronchial Aspiration Needle. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Broncus Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on April 26, 2024 after a review of 291 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4680 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Broncus Medical, Inc. devices

Submission Details

510(k) Number K232038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2023
Decision Date April 26, 2024
Days to Decision 291 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 139d · This submission: 291d
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 Anesthesiology 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 K232038.
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