Cleared Traditional

K011657 - HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011657 · Mick Radio-Nuclear Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
90d
Days
Class 2
Risk

K011657 is an FDA 510(k) clearance for the HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Mick Radio-Nuclear Instruments, Inc. (Mt. Vernon, US). The FDA issued a Cleared decision on August 27, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 Mick Radio-Nuclear Instruments, Inc. devices

Submission Details

510(k) Number K011657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2001
Decision Date August 27, 2001
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 205
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K011657.
Rectal Applicator
K251037 · Nucletron B.V. · Dec 2025
Guided Aarhus Applicator Set
K252884 · Varian Medical Systems · Nov 2025
CT/ MR Tandem and Ovoid Set
K250299 · Varian Medical Systems, Inc. · May 2025
Intracavitary/Interstitial System
K250289 · Varian Medical Systems · Apr 2025
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
K243939 · Varian Medical Systems, Inc. · Mar 2025
Mould Probe MR Safe
K241764 · Varian Medical Systems, Inc. · Jan 2025