Cleared Traditional

RHIN1 Stylus (K192471) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence.

K192471 · Aerin Medical, Inc. · Ear, Nose, Throat device
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Dec 2019
Decision
101d
Days
Class 2
Risk

K192471 is an FDA 510(k) clearance for the RHIN1 Stylus. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Aerin Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 20, 2019 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 878.4400 - 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 Aerin Medical, Inc. devices

Submission Details

510(k) Number K192471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2019
Decision Date December 20, 2019
Days to Decision 101 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
12d slower than avg
Panel avg: 89d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02914236 Completed Interventional Industry-sponsored

Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

A Prospective, Multi-Center Non-Randomized Study to Evaluate Treatment of Nasal Airway Obstruction Using the Aerin Medical Device

50
Patients (actual)
9
Sites
Treatment
Purpose
Open label
Masking
Condition studied Nasal Obstruction
Study design Single group
Eligibility All sexes · 22 Years+
Principal investigator Scott Wolf, MD
Sponsor Aerin Medical (industry)
Started 2016-09-27 → Primary completion 2017-07-21 → Completed 2017-08-18
Primary outcome
Improvement in NOSE Score
Secondary outcome
NOSE Responder Rate
View full study on ClinicalTrials.gov

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 694
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K192471.
InMode System with the Morpheus8 (Fractora) Applicators
K192695 · Inmode MD , Ltd. · Dec 2019
APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets
K191234 · Erbe Elektromedizin GmbH · Dec 2019
WEREWOLF COBLATION System, COBLATION HALO Wand
K192027 · ArthroCare Corporation · Dec 2019
Surgical Direct Hand-held Laparoscopic Instruments
K193018 · Surgical Direct, Inc. · Dec 2019
Voyant 5mm Fusion Device, Voyant Maryland Fusion Device
K193292 · Applied Medical Resources Corp. · Dec 2019
Monopolar Cord
K193004 · New Deantronics Taiwan , Ltd. · Dec 2019