Cleared Traditional

K850815 - RADIOISOTOPE CALIBRATOR MODEL 34-062

K850815 is an FDA 510(k) clearance for RADIOISOTOPE CALIBRATOR MODEL 34-062, manufactured by Victoreen, Inc.. The device is a Class 2 Radiology device with product code KPT cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K850815 · Victoreen, Inc. · Radiology device
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Aug 1985
Decision
174d
Days
Class 2
Risk

K850815 is an FDA 510(k) clearance for the RADIOISOTOPE CALIBRATOR MODEL 34-062. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Victoreen, Inc. (Carle Place, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 174 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1360 - 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 Victoreen, Inc. devices

FDA 510(k) Submission Details - K850815

510(k) Number K850815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1985
Decision Date August 21, 1985
Days to Decision 174 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 107d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPT Device Classification - Class 2, Special Controls

Product Code KPT Calibrator, Dose, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1360
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 - KPT Calibrator, Dose, Radionuclide

All 12
Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K850815.
PET-DOSE
K042746 · Comecer S.R.L. · Nov 2004
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
K011493 · Mentor Corp. · Oct 2002
NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.
K931657 · Victoreen, Inc. · Jul 1993
B.D.A.S.
K813065 · General Electric Co. · Dec 1981
DISPENSER, TECHNETIUM, CLINTICHEM
K770515 · Union Carbide Corp. · Apr 1977