510(k) Report

510(k) · Cleared

Cleared

Gammamed 212 and 232 Source Assembly

K030745510(k) TraditionalCleared Mar 12, 20032-day reviewClass II21 CFR 892.5730

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Varian Medical Systems · KXK Source, Brachytherapy, Radionuclide

Cleared on Mar 12, 2003 as substantially equivalent to K891131 (Mick Radio-Nuclear Instruments, Inc., 1989) after a 2-day review. Its family tree reaches back 1 generation to 1989. 7 later devices descend from it.

Decided
Mar 12, 2003
Review
2 days
Class
Class II
Product code
KXK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K891131 (1989). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 1 descendant cleared2007: 1 descendant cleared2009: 2 descendants cleared2016: 1 descendant cleared2014: 1 descendant clearedK891131 · Gammamed 12I · Mick Radio-Nuclear Instruments, Inc. · 1989 · recalled1990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant K891131 · Gammamed 12I · Mick Radio-Nuclear Instruments, Inc. · 1989 · recalled0
  1. Root · 1 generation backK891131 Gammamed 12IMick Radio-Nuclear Instruments, Inc. · 1989 · Recalled
  2. This deviceK030745 Gammamed 212 and 232 Source AssemblyVarian Medical Systems · 2003
  3. Descendant · cites it directly · 4 of its ownK042864 Implant Sciences Corp, Model HDR-4140Implant Sciences Corp. · 2005
  4. Descendant · 2 generations on · 1 of its ownK090366 Spec Model M-31Source Production & Equipment Co., Inc. · 2009
  5. Descendant · cites it directly · 1 of its ownK052947 Source Production & Equipment CO, Inc., Model M-19 IR-192…Source Production & Equipment Co., Inc. · 2006 · Recalled
  6. Descendant · 2 generations on · 0 of its ownK161396 SPEC Model M23Source Production and Equipment Co., Inc. · 2016
  7. Descendant · 3 generations on · 0 of its ownK141038 Ant Model 1Advanced Nuclide Technologies, LLC · 2014

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12009: 22014: 12016: 1
2005high 2 (2009) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K042864Implant Sciences Corp, Model HDR-4140Implant Sciences Corp. · 2005 · cites it directly4descendants
  • K090366Spec Model M-31Source Production & Equipment Co., Inc. · 2009 · 2 generations on1descendant
  • K052947Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy SourceSource Production & Equipment Co., Inc. · 2006 · cites it directly1descendant
  • K161396SPEC Model M23Source Production and Equipment Co., Inc. · 2016 · 2 generations on0descendants
  • K141038Ant Model 1Advanced Nuclide Technologies, LLC · 2014 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K891131Gammamed 12IMick Radio-Nuclear Instruments, Inc.19894
0 (this device)K030745Gammamed 212 and 232 Source AssemblyVarian Medical Systems2003—
+1K042864Implant Sciences Corp, Model HDR-4140Implant Sciences Corp.2005—
+2K090366Spec Model M-31Source Production & Equipment Co., Inc.2009—
+1K052947Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy SourceSource Production & Equipment Co., Inc.20061
+2K161396SPEC Model M23Source Production and Equipment Co., Inc.2016—
+3K141038Ant Model 1Advanced Nuclide Technologies, LLC2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200920
201410
201610
FIG. 1 — Lineage of K030745, 1989–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KXK device

  1. #1 K242818 IsoSpherescore 10.9 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K891131Gammamed 12I
Summary page 1
…Gammamed 2 12 and 232 Source Assembly Proprietary Name: Gammamed 212 and 232 Source Assembly 3. Equivalent Device: Gammamed 12i, K89 1 13 1 4.Device Description: The Gammamed 212 and 232 Source Assemblies are brachytherapy sources that are used in…
Mick Radio-Nuclear Instruments, Inc.19894

Also cleared against K891131: 1 other device →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042864Implant Sciences Corp, Model HDR-4140Implant Sciences Corp.20054
K052947Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy SourceSource Production & Equipment Co., Inc.20061

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K042864 (Implant Sciences Corp., 2005) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K891131.

How does its category compare?

All KXK devices

KXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXK

2in 2025

2007: 52008: 12009: 72010: 12011: 52012: 32013: 32014: 82015: 22016: 42017: 22018: 12019: 22020: 32022: 12023: 12025: 2
2007high 8 (2014) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KXK

158in 2020

2007: 42 days median2009: 63 days median2011: 94 days median2012: 109 days median2013: 127 days median2014: 96 days median2016: 49 days median2020: 158 days median
2007high 158 (2020) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KXK

1in 2016

2008: 12011: 12012: 12016: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KXK

7in 2025

2007: 92008: 152009: 102011: 352012: 42013: 292014: 132015: 62016: 402017: 412018: 282019: 102020: 152021: 622022: 262023: 92024: 152025: 7
2007high 62 (2021) · low 0 (2010)2025

MAUDE reports naming product code KXK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200754209
20081—115
2009763010
20101—00
2011594135
2012310914
20133127029
2014896013
20152—06
2016449140
20172—041
20181—028
20192—010
20203158015
20210—062
20221—026
20231—09
20240—015
20252—07
20260—0—

What is it indicated for?

The Gammamed Model 212 and 232 source assembly is designed to be used in conditions typically associated with hospitals and medical facilities for the treatment of cancerous tumors.

Indications for use as stated in the FDA summary.

Also cleared against K891131

1 other device cites the same predicate.

  • K063815Varian Esophagus Bougie ApplicatorVarian Medical Systems · 2007

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The KXK category page

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https://510kreport.com/device/K030745 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030745: Gammamed 212 and 232 Source Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030745

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026