Cleared Traditional

K242185 - Rextar Pro

K242185 is an FDA 510(k) clearance for Rextar Pro, manufactured by Raypia Co., Ltd.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K242185 · Raypia Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
132d
Days
Class 2
Risk

K242185 is an FDA 510(k) clearance for the Rextar Pro. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Raypia Co., Ltd. (Gangseo-Gu, Seoul, KR). The FDA issued a Cleared decision on December 4, 2024 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Raypia Co., Ltd. devices

FDA 510(k) Submission Details - K242185

510(k) Number K242185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2024
Decision Date December 04, 2024
Days to Decision 132 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 107d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 80
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K242185.
Portable Dental X-ray Device (GT-1)
K254018 · Guilin Refine Medical Instrument Co., Ltd. · Feb 2026
Diagnostic X-Ray Equipment Model POCT22
K252909 · Ningbo Runyes Medical Instrument Co., Ltd. · Feb 2026
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
K251438 · Guilin Woodpecker Medical Instrument Co., Ltd. · Sep 2025
XERO-alpha
K242591 · DRTECH Corporation · Nov 2024
WERAY
K241963 · Picopack Co., Ltd. · Jul 2024
LifeRay Intraoral Handheld X-ray System
K241305 · Lucas Lifecare · Jul 2024