510(k) Report

510(k) · Cleared

Cleared

10 Curie Irdium 192, CSN00100-192

K991571510(k) TraditionalCleared Feb 22, 2000293-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

Alpha-Omega Services, Inc. · KXK Source, Brachytherapy, Radionuclide

Cleared on Feb 22, 2000 as substantially equivalent to K864210 (Nucletron-Oldelft Corp., 1986) after a 293-day review. Its family tree reaches back 1 generation to 1986. 11 later devices descend from it.

Decided
Feb 22, 2000
Review
293 days
Class
Class II
Product code
KXK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K864210 (1986). 11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2014: 2 descendants cleared2006: 1 descendant cleared2007: 1 descendant cleared2009: 2 descendants cleared2016: 3 descendants cleared2015: 1 descendant clearedK864210 · Microselectron-HDR (High Dose Rate) · Nucletron-Oldelft Corp. · 19861990200020102020
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 1 descendant K864210 · Microselectron-HDR (High Dose Rate) · Nucletron-Oldelft Corp. · 19860
  1. Root · 1 generation backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
  2. This deviceK991571 10 Curie Irdium 192, CSN00100-192Alpha-Omega Services, Inc. · 2000
  3. Descendant · cites it directly · 4 of its ownK042864 Implant Sciences Corp, Model HDR-4140Implant Sciences Corp. · 2005
  4. Descendant · cites it directly · 3 of its ownK132969 Spec Model M15Source Production & Equipment Co., Inc. · 2014
  5. Descendant · 2 generations on · 1 of its ownK090366 Spec Model M-31Source Production & Equipment Co., Inc. · 2009
  6. 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
  7. Descendant · 2 generations on · 0 of its ownK162573 Source Production & Equipment Co., Inc. Model M14 192Iridium…Source Production and Equipment Co., Inc. · 2016

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12009: 22014: 22015: 12016: 3
2005high 3 (2016) · low 0 (2008)2026

Most influential descendants

Showing 5 of 11 · See all
  • K042864Implant Sciences Corp, Model HDR-4140Implant Sciences Corp. · 2005 · cites it directly4descendants
  • K132969Spec Model M15Source Production & Equipment Co., Inc. · 2014 · cites it directly3descendants
  • 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
  • K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy SourceSource Production and Equipment Co., Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K864210Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp.1986—
0 (this device)K99157110 Curie Irdium 192, CSN00100-192Alpha-Omega Services, Inc.2000—
+1K042864Implant Sciences Corp, Model HDR-4140Implant Sciences Corp.2005—
+1K132969Spec Model M15Source Production & Equipment Co., Inc.2014—
+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
+2K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy…Source Production and Equipment Co., Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200920
201420
201510
201630
FIG. 1 — Lineage of K991571, 1986–2016Source: 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
Get a 510(k) Report

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
*K864210Microselectron-HDR (High Dose Rate)
Summary page 1
…!l, Product Code: JAQ Special Controls Product will comply with the nuclear regulatory requirements for the State of Louisiana NRC and US NRC. Substantial Equivalence K864210 Nucletron Microselection Source. The contents of this premarket notification summary will demonstrate the substantial equivalenc…
Nucletron-Oldelft Corp.1986—

Also cleared against K864210: 3 other devices →

What descends from it? (11)

See all 11

3 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
K132969Spec Model M15Source Production & Equipment Co., Inc.20143
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 no recall.
  • Of its descendants, K042864 (Implant Sciences Corp., 2005) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K864210.

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?

A high specific activity radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. Device is the active source for a Nucletron Microselection Device.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K864210

3 other devices cite the same predicate.

  • K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2002
  • K983115Treatment Control Station - Microselectron-HDR Classic Upgrade, Version 1.20Nucletron Corp. · 1999
  • K953946Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996

More from Alpha-Omega Services, Inc.

9 FDA decisions under this applicant name. See the company

  • K233628AOS Interstitial Templates, Needles, and AccessoriesAlpha-Omega Services, Inc. · 2024
  • K233626AOS Marker Seeds (SMG0242-025)Alpha-Omega Services, Inc. · 2024
  • K102811Aos Orion IR-192 Source CableAlpha-Omega Services, Inc. · 2011
  • K062824Aos Universal Conecting Guide TubeAlpha-Omega Services, Inc. · 2007
  • K062823Aos Interstitial Templates, Needles & AccessoriesAlpha-Omega Services, Inc. · 2007

Recent decisions in KXK

The KXK category page

  • K252296OncoPatchOncopatch, Inc. · 2025
  • K242818IsoSphereIsoaid, LLC · 2025
  • K223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc. · 2023
  • K221539GammaTileGt Medical Technologies · 2022
  • K202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc. · 2020

https://510kreport.com/device/K991571 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991571: 10 Curie Irdium 192, CSN00100-192.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991571

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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