Cleared Traditional

SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 (K100847) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100847 · Biocompatibles, Inc. · Radiology device
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May 2010
Decision
57d
Days
Class 2
Risk

K100847 is an FDA 510(k) clearance for the SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X .... Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Biocompatibles, Inc. (Oxford, US). The FDA issued a Cleared decision on May 21, 2010 after a review of 57 days - a notably fast clearance 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: 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 Biocompatibles, Inc. devices

Submission Details

510(k) Number K100847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2010
Decision Date May 21, 2010
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
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 17
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K100847.
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
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · C.R. Bard, Inc. · Feb 2005