Cleared Traditional

K140490 - CIVA SHEET PD-103

K140490 is the FDA 510(k) clearance for CIVA SHEET PD-103 by Civatech Oncology, Inc.. It is a Class 2 Radiology device (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

Submission Details

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
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 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 19
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K140490.
GammaTile
K190296 · Gt Medical Technologies · Mar 2019
GammaTile
K180515 · Isoray Medical, Inc. · Jul 2018
VariSeed 9.0
K150636 · Varian Medical Systems, Inc. · May 2015
BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
K140856 · C.R. Bard, Inc. · May 2014
RADIONUCLIDE BRACHYTHERAPY SOURCE
K093663 · C.R. Bard, Inc. · Dec 2009
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
K060636 · C.R. Bard, Inc. · Apr 2006