Cleared Traditional

K842570 - LUDLUM 88 DOSE CALIBRATOR

K842570 is an FDA 510(k) clearance for LUDLUM 88 DOSE CALIBRATOR, manufactured by Ludlum Measurements, Inc.. The device is a Class 2 Radiology device with product code KPT cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K842570 · Ludlum Measurements, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
35d
Days
Class 2
Risk

K842570 is an FDA 510(k) clearance for the LUDLUM 88 DOSE CALIBRATOR. Classified as Calibrator, Dose, Radionuclide (product code KPT), Class II - Special Controls.

Submitted by Ludlum Measurements, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1984 after a review of 35 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ludlum Measurements, Inc. devices

FDA 510(k) Submission Details - K842570

510(k) Number K842570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1984
Decision Date August 07, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 107d · This submission: 35d
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 15
Devices cleared under the same product code (KPT) and FDA review panel - the closest regulatory comparables to K842570.
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
K002833 · Standard Imaging, Inc. · Sep 2000
NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.
K931657 · Victoreen, Inc. · Jul 1993
RADIOISOTOPE CALIBRATOR MODEL 34-062
K850815 · Victoreen, Inc. · Aug 1985
B.D.A.S.
K813065 · General Electric Co. · Dec 1981
DISPENSER, TECHNETIUM, CLINTICHEM
K770515 · Union Carbide Corp. · Apr 1977