510(k) Report

510(k) · Cleared

Cleared

I-125 Seeds, Code: 6711

K914281510(k) TraditionalCleared Nov 22, 199159-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

Medi-Physics Inc. Dba Nycomed Amersham Imaging · KXK Source, Brachytherapy, Radionuclide

Cleared on Nov 22, 1991 after a 59-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 32 later devices descend from it.

Decided
Nov 22, 1991
Review
59 days
Class
Class II
Product code
KXK
Recalls
None
Predicates
0

32 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2002: 1 descendant cleared1999: 5 descendants cleared2003: 1 descendant cleared1998: 1 descendant cleared2008: 1 descendant cleared2014: 2 descendants cleared2000: 1 descendant cleared2006: 3 descendants cleared2004: 2 descendants cleared2009: 4 descendants cleared2005: 1 descendant cleared2012: 2 descendants cleared2007: 1 descendant cleared2018: 1 descendant cleared2020: 2 descendants cleared2025: 1 descendant cleared2019: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK914281 I-125 Seeds, Code: 6711Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1991
  2. Descendant · cites it directly · 17 of its ownK030594 I-125 Rapid Strand, Model 7000Amersham Health · 2003
  3. Descendant · 2 generations on · 14 of its ownK040339 Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH · 2004
  4. Descendant · 3 generations on · 9 of its ownK043596 Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005
  5. Descendant · cites it directly · 9 of its ownK984235 Intersource 125, Model 1251LInternational Brachytherapy, Inc. · 1999
  6. Descendant · 2 generations on · 8 of its ownK041702 EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)Ibt SA · 2004

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

1998: 11999: 52000: 12002: 12003: 12004: 22005: 12006: 32007: 12008: 12009: 42011: 12012: 22014: 22018: 12019: 12020: 22022: 12025: 1
1998high 5 (1999) · low 0 (2001)2026

Most influential descendants

Showing 5 of 32 · See all
  • K030594I-125 Rapid Strand, Model 7000Amersham Health · 2003 · cites it directly17descendants
  • K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH · 2004 · 2 generations on14descendants
  • K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp. · 2005 · 3 generations on9descendants
  • K984235Intersource 125, Model 1251LInternational Brachytherapy, Inc. · 1999 · cites it directly9descendants
  • K041702EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)Ibt SA · 2004 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914281I-125 Seeds, Code: 6711Medi-Physics Inc. Dba Nycomed Amersham Imaging1991—
+1K030594I-125 Rapid Strand, Model 7000Amersham Health2003—
+2K040339Brachytherapy Strand DeviceBebig Isotopen-Und Medizintechnik GmbH2004—
+3K043596Theraload Custom Loaded Needles, Models 200 and 125.S06Theragenics Corp.2005—
+1K984235Intersource 125, Model 1251LInternational Brachytherapy, Inc.1999—
+2K041702EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.)Ibt SA2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199950
200010
200210
200310
200420
200510
200630
200710
200810
200940
201110
201220
201420
201810
201910
202020
202210
202510
FIG. 1 — Lineage of K914281, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K030594I-125 Rapid Strand, Model 7000Amersham Health200317
K984235Intersource 125, Model 1251LInternational Brachytherapy, Inc.19999
K982421Imagyn 125 I Seed, Model IS 125International Isotopes, Inc.19986
K990193Iodine Brachytherapy Seeds, Model 3000Implant Sciences Corp.19994
K994317I-Plant, Model 3500Implant Sciences Corp.20002
K140849IsoseedEckert & Ziegler Bebig GmbH20140
K103319I-SEEDTheragenics Corp.20110
K081066Brachytherapy Source Device, Model 9011Medi-Physics, Inc., Dba GE Healthcare20080
K023242I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-SterileImplant Sciences Corp.20020
K992963I3RAD 125 I Brachytherapy Seed, Model I125-0401International Isotopes, Inc.19990

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?

  • Of its descendants, K030594 (Amersham Health, 2003) has gone furthest, with 17 descendants of its own.

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—

More from Medi-Physics Inc. Dba Nycomed Amersham…

9 FDA decisions under this applicant name. See the company

  • K010821Echoseed/Iodine-125 Seeds, Model 6733Medi-Physics Inc. Dba Nycomed Amersham Imaging · 2001
  • K940632I-125 Rapid StrandMedi-Physics Inc. Dba Nycomed Amersham Imaging · 1994
  • K921961Sdmo Applicator Code: Asn.8236Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1992
  • K915156I-125 Seeds Code: 6702Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1992
  • K914268I-125 Seeds in Carrier, Code: 6720Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1991

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/K914281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K914281: I-125 Seeds, Code: 6711.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914281

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026