Cleared Traditional

K140490 - CIVA SHEET PD-103

K140490 is an FDA 510(k) clearance for CIVA SHEET PD-103, manufactured by Civatech Oncology, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K140490 · Civatech Oncology, Inc. · Radiology device
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Aug 2014
Decision
183d
Days
Class 2
Risk

K140490 is an FDA 510(k) clearance for the CIVA SHEET PD-103. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Civatech Oncology, Inc. (Mt. Airy, US). The FDA issued a Cleared decision on August 29, 2014 after a review of 183 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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 Civatech Oncology, Inc. devices

FDA 510(k) Submission Details - K140490

510(k) Number K140490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2014
Decision Date August 29, 2014
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.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 - KXK Source, Brachytherapy, Radionuclide

All 84
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K140490.
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE]
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Lesion-Loc Iodine I-125 Seed/Needle
K142668 · Intramedical Imaging, LLC · Nov 2014
ANT MODEL 1
K141038 · Advanced Nuclide Technologies, LLC · Nov 2014
ISOSEED
K140849 · Eckert & Ziegler Bebig GmbH · Jul 2014
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K140856 · C.R. Bard, Inc. · May 2014
SPEC MODEL M15
K132969 · Source Production & Equipment Co., Inc. · Jan 2014