Cleared Special

K181193 - PeriView FLEX (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
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 32
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K181193.
ClearTip TBNA Type
K251478 · Finemedix Co., Ltd. · Apr 2026
LungFlow Basket Catheter
K254040 · Free Flow Medical, Inc. · Mar 2026
LIA-1 Catheter (542-1)
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
K250263 · Olympus Medical Systems Corp. · Mar 2025