Cleared Traditional

K001544 - VAGINAL APPLICATOR SHIELDED

K001544 is the FDA 510(k) clearance for VAGINAL APPLICATOR SHIELDED by Mick Radio-Nuclear Instruments, Inc.. It is a Class 2 Radiology device (product code JAQ) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K001544 · Mick Radio-Nuclear Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
183d
Days
Class 2
Risk

K001544 is an FDA 510(k) clearance for the VAGINAL APPLICATOR SHIELDED. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Mick Radio-Nuclear Instruments, Inc. (Bronx, US). The FDA issued a Cleared decision on November 17, 2000 after a review of 183 days - an extended review cycle.

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 K001544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2000
Decision Date November 17, 2000
Days to Decision 183 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
76d slower than avg
Panel avg: 107d · This submission: 183d
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 101
Devices cleared under the same product code (JAQ) and FDA review panel - the closest regulatory comparables to K001544.
VARISOURCE BREAST TEMPLATE SYSTEM
K023220 · Varian Medical Systems · Oct 2002
HDR MIAMI APPLICATOR
K020176 · Mick Radio-Nuclear Instruments, Inc. · Apr 2002
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
K011657 · Mick Radio-Nuclear Instruments, Inc. · Aug 2001
SEGMENTED VAGINAL APPLICATOR
K993472 · Mick Radio-Nuclear Instruments, Inc. · Jan 2000
HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
K993400 · Mick Radio-Nuclear Instruments, Inc. · Jan 2000
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K990753 · Cook, Inc. · May 1999