Cleared Special

PeriView FLEX (K181193) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181193 · Olympus Surgical Technologies America · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
60d
Days
Class 2
Risk

K181193 is an FDA 510(k) clearance for the PeriView FLEX. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Olympus Surgical Technologies America (Southborough, US). The FDA issued a Cleared decision on July 3, 2018 after a review of 60 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Olympus Surgical Technologies America devices

Submission Details

510(k) Number K181193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2018
Decision Date July 03, 2018
Days to Decision 60 days
Submission Type Special
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
29d faster than avg
Panel avg: 89d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

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 K181193.
Trachealator
K211894 · Disa Medinotec · Nov 2021
ViziShot 2 FLEX
K193517 · Olympus Surgical Technologies America · Mar 2020
Single Use Aspiration Needle
K190239 · Olympus Medical Systems Corp. · Dec 2019
CRE Pulmonary Balloon Dilatation Catheter
K170759 · Boston Scientific Corporation · Jun 2017
Elation Pulmonary Balloon Dilation
K161392 · Merit Medical Systems, Inc. · Sep 2016
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
K023337 · Boston Scientific Corp · Nov 2002