Cleared Traditional

K232293 - kallisio stentra oral stent

K232293 is an FDA 510(k) clearance for kallisio stentra oral stent, manufactured by Kallisio, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K232293 · Kallisio, Inc. · Radiology device
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Dec 2023
Decision
143d
Days
Class 2
Risk

K232293 is an FDA 510(k) clearance for the kallisio stentra™ oral stent. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Kallisio, Inc. (Houston, US). The FDA issued a Cleared decision on December 22, 2023 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kallisio, Inc. devices

FDA 510(k) Submission Details - K232293

510(k) Number K232293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2023
Decision Date December 22, 2023
Days to Decision 143 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 107d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

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