510(k) Report

510(k) · Cleared

Recalled · 2008

Poiint of Care Stranding System, Mode 1004-00

K072296510(k) AbbreviatedCleared Sep 26, 200740-day reviewClass II21 CFR 892.5730Recalls 1

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

Theragenics Corp. · KXK Source, Brachytherapy, Radionuclide

Cleared on Sep 26, 2007 as substantially equivalent to K040339 (Bebig Isotopen-Und Medizintechnik GmbH, 2004) and 3 other predicates after a 40-day review. Its family tree reaches back 4 generations to 1980. It has been recalled once.

Decided
Sep 26, 2007
Review
40 days
Class
Class II
Product code
KXK
Recalls
1
Predicates
4

Its longest line of descent runs back 4 generations to K801748 (1980). 17 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2002: 2 other ancestors1989: 1 other ancestor2003: 1 other ancestor2001: 2 other ancestors1995: 1 other ancestor1997: 2 other ancestors1994: 1 other ancestor1991: 1 other ancestor1987: 1 other ancestorK801748 · 3M I-125 Seeds in Absorbable Carrier · 3M Company · 1980K982226 · Uromed Brachytheraphy Iodine-125 Sources · Uromed Corp. · 1999K021343 · Isoseeds I-125 · Bebig Isotopen-Und Medizintechnik GmbH · 2002K040339 · Brachytherapy Strand Device · Bebig Isotopen-Und Medizintechnik GmbH · 2004198019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 6 other ancestors K040339 · Brachytherapy Strand Device · Bebig Isotopen-Und Medizintechnik GmbH · 2004K021343 · Isoseeds I-125 · Bebig Isotopen-Und Medizintechnik GmbH · 2002K982226 · Uromed Brachytheraphy Iodine-125 Sources · Uromed Corp. · 1999K801748 · 3M I-125 Seeds in Absorbable Carrier · 3M Company · 19800
  1. Root · 4 generations backK801748 3M I-125 Seeds in Absorbable Carrier3M Company · 1980
  2. 3 generations backK982226 Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999
  3. 2 generations backK021343 Isoseeds I-125Bebig Isotopen-Und Medizintechnik GmbH · 2002
  4. 1 generation backK040339 Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH · 2004
  5. This deviceK072296 Poiint of Care Stranding System, Mode 1004-00Theragenics Corp. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K8017483M I-125 Seeds in Absorbable Carrier3M Company1980—
−3K982226Uromed Brachytheraphy Iodine-125 SourcesUromed Corp.1999—
−2K021343Isoseeds I-125Bebig Isotopen-Und Medizintechnik GmbH2002—
−1K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH2004—
0 (this device)K072296Poiint of Care Stranding System, Mode 1004-00Theragenics Corp.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199110
199410
199510
199720
200120
200220
200310
200410
FIG. 1 — Lineage of K072296, 1980–2007Source: 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? (4)

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
*K040339Brachytherapy Strand Device
Summary page 1
…: 1004-00 Classification Name: Radionuclide Brachytherapy Source (KXK) Device Classification: Class II Predicate Devices: TheraStrand (K040339) CP Spacer (K013964) MICK 200-TPV Applicator (K890341)…
Bebig Isotopen-Und Medizintechnik GmbH2004—
*K013964Modification to Accu-Space Plain Gut Absorbable Seeding Spacers
Summary page 1
…Radionuclide Brachytherapy Source (KXK) Device Classification: Class II Predicate Devices: TheraStrand (K040339) CP Spacer (K013964) MICK 200-TPV Applicator (K890341) Bard Sourcelink (K041576) Manufactu…
Cp Medical2002—
*K890341Mick 200-TP and Mick TP Needle
Summary page 1
…Class II Predicate Devices: TheraStrand (K040339) CP Spacer (K013964) MICK 200-TPV Applicator (K890341) Bard Sourcelink (K041576) Manufacturer: Theragenics Corporation®…
Mick Radio-Nuclear Instruments, Inc.19891
*K041576Sourcelink
Summary page 1
…d (K040339) CP Spacer (K013964) MICK 200-TPV Applicator (K890341) Bard Sourcelink (K041576) Manufacturer: Theragenics Corporation® 5203 Bristol Industrial Way…
C.R. Bard, Inc.2004—

Also cleared against K040339: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 8, 2008Not classifiedZ-1020-2009Packaging process controlSome pouches were found to have weak seals potentially compromising sterility.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
  • 3 of the 17 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K040339.

How does its category compare?

All KXK devices

KXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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 Point of Care Stranding System provides a method for the physician to custom configure and assemble sterile TheraSeed® strands in the operating room at the time of the implant procedure.

The Point of Care System may also be used to custom load sterile I-Seed in non-stranded configurations.

Indications for use as stated in the FDA summary.

Also cleared against K040339

4 other devices cite the same predicate.

  • K113210Advantage-Strand/Advantage-Load Brachytherapy KitIsoaid, LLC · 2012
  • K091117Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model IaslbkaIsoaid, LLC · 2009
  • K062384Cesium-131 Strand, Strand Preload, Preload, S-CartridgeIsoray, Inc. · 2006
  • K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005

More from Theragenics Corp.

5 FDA decisions under this applicant name. See the company

  • K103319I-SEEDTheragenics Corp. · 2011
  • K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005
  • K010283Theraseed (R) Palladium-103 Implant; Model 200Theragenics Corp. · 2001
  • K874787Modified Palladium Seed Model 100Theragenics Corp. · 1987

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/K072296 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072296: Poiint of Care Stranding System, Mode 1004-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072296

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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