Cleared Traditional

K193517 - ViziShot 2 FLEX

K193517 is an FDA 510(k) clearance for ViziShot 2 FLEX, manufactured by Olympus Surgical Technologies America. The device is a Class 2 Anesthesiology device with product code KTI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K193517 · Olympus Surgical Technologies America · Anesthesiology device
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Mar 2020
Decision
90d
Days
Class 2
Risk

K193517 is an FDA 510(k) clearance for the ViziShot 2 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 March 18, 2020 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4680 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Surgical Technologies America devices

FDA 510(k) Submission Details - K193517

510(k) Number K193517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2019
Decision Date March 18, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTI Device Classification - Class 2, Special Controls

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 Anesthesiology devices follow this clearance model.

Regulatory Peers - KTI Bronchoscope Accessory

All 23
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K193517.
AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
K213060 · Micro-Tech (Nanjing) Co., Ltd. · Jul 2022
Elation Pulmonary Balloon Dilation Catheter
K213434 · Merit Medical Systems, Inc. · Mar 2022
Trachealator
K211894 · Disa Medinotec · Nov 2021
Single Use Aspiration Needle
K190239 · Olympus Medical Systems Corp. · Dec 2019
PeriView FLEX
K181193 · Olympus Surgical Technologies America · Jul 2018
CRE Pulmonary Balloon Dilatation Catheter
K170759 · Boston Scientific Corporation · Jun 2017