Cleared Traditional

K213434 - Elation Pulmonary Balloon Dilation Catheter (FDA 510(k) Clearance)

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

K213434 · Merit Medical Systems, Inc. · Ear, Nose, Throat device
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Mar 2022
Decision
137d
Days
Class 2
Risk

K213434 is an FDA 510(k) clearance for the Elation Pulmonary Balloon Dilation Catheter. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 8, 2022 after a review of 137 days - within the typical 510(k) review window.

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 Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K213434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2021
Decision Date March 08, 2022
Days to Decision 137 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
48d slower than avg
Panel avg: 89d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTI Bronchoscope Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition 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 - KTI Bronchoscope Accessory

All 32
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K213434.
ClearTip TBNA Type
K251478 · Finemedix Co., Ltd. · Apr 2026
LungFlow Basket Catheter
K254040 · Free Flow Medical, Inc. · Mar 2026
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K251402 · Leadoptik, Inc. · Dec 2025
Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
K252874 · Serpex Medical, Inc. · Oct 2025
Single Use Aspiration Needle (NA-201SX-4021)
K251664 · Olympus Medical Systems Corporation · Jul 2025
Disposable Grasping Forceps FG-52D/FG-54D
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