Cleared Traditional

Portare System (FA-001)

K243639 · Grumpy Innovation, Inc. · Ear, Nose, Throat

Jun 2025

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K243639 is an FDA 510(k) clearance for the Portare System (FA-001), a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Grumpy Innovation, Inc. (Sioux Falls, US). The FDA issued a Cleared decision on June 5, 2025, 192 days after receiving the submission on November 25, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K243639 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2024
Decision Date	June 05, 2025
Days to Decision	192 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
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).