Cleared Traditional

K200652 - Lollipop BiteBlock

K200652 is an FDA 510(k) clearance for Lollipop BiteBlock, manufactured by Radtec Medical Devices, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K200652 · Radtec Medical Devices, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
116d
Days
Class 2
Risk

K200652 is an FDA 510(k) clearance for the Lollipop BiteBlock. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Radtec Medical Devices, Inc. (San Carlos, US). The FDA issued a Cleared decision on July 6, 2020 after a review of 116 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 Radtec Medical Devices, Inc. devices

FDA 510(k) Submission Details - K200652

510(k) Number K200652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2020
Decision Date July 06, 2020
Days to Decision 116 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
9d slower than avg
Panel avg: 107d · This submission: 116d
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 Consultant

Acknowledge Regulatory Strategies, LLC
Michelle Rubin-Onur

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 528
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K200652.
The AIO Solution 3.0
K202068 · Orfit Industries NV · Aug 2020
TaiChiA
K193207 · Our United Corporation · Aug 2020
ExacTrac Dynamic
K201276 · Brainlab AG · Jul 2020
ChartCheck
K201119 · Radformation, Inc. · Jun 2020
Gold Anchor
K201117 · Naslund Medical AB · Jun 2020
Thales 3D Mr Scanner
K200907 · Lap GmbH Laser Applikationen · Jun 2020