Cleared Traditional

K131234 - LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)

K131234 is an FDA 510(k) clearance for LUNGPOINT TOOLS (LUNGPOINT SHEATH, manufactured by Broncus Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K131234 · Broncus Medical, Inc. · Ear, Nose, Throat device
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Oct 2013
Decision
167d
Days
Class 2
Risk

K131234 is an FDA 510(k) clearance for the LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON). Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Broncus Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 15, 2013 after a review of 167 days - an extended review 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: 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.

View all Broncus Medical, Inc. devices

FDA 510(k) Submission Details - K131234

510(k) Number K131234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2013
Decision Date October 15, 2013
Days to Decision 167 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 90d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 224
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FDA 510(k) Resources - Ear, Nose, Throat

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.