Cleared Traditional

METIC™- Airway Balloon Catheter (K231818) - FDA 510(k) Clearance

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

K231818 · M/S Meril Life Sciences Pvt. , Ltd. · Ear, Nose, Throat device
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Nov 2023
Decision
147d
Days
Class 2
Risk

K231818 is an FDA 510(k) clearance for the METIC™- Airway Balloon Catheter. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by M/S Meril Life Sciences Pvt. , Ltd. (Vapi, IN). The FDA issued a Cleared decision on November 15, 2023 after a review of 147 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 M/S Meril Life Sciences Pvt. , Ltd. devices

Submission Details

510(k) Number K231818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2023
Decision Date November 15, 2023
Days to Decision 147 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
58d slower than avg
Panel avg: 89d · This submission: 147d
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 21
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K231818.
Single Use Aspiration Needle (NA-201SX-4021)
K251664 · Olympus Medical Systems Corporation · Jul 2025
Disposable Grasping Forceps FG-52D/FG-54D
K250263 · Olympus Medical Systems Corp. · Mar 2025
Disposable Cytology Brush (AF series)
K241679 · Alton (Shanghai) Medical Instruments Co., Ltd. · Mar 2025
EndoCore
K230778 · Praxis Medical, LLC · Sep 2023
ANDORATE® Suction Valve and ANDORATE® Biopsy Valve
K230280 · Ga Health Company Limited · May 2023
Multistage Balloon Dilatation Catheter
K222187 · Dongguan TT Medical, Inc. · Mar 2023