510(k) Report

510(k) · Cleared

Cleared

Isostar I-125 Interstitial Seed, Model IS-12501

K991526510(k) SpecialCleared Jun 17, 199945-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

Imagyn Medical Technologies, Inc. · KXK Source, Brachytherapy, Radionuclide

Cleared on Jun 17, 1999 as substantially equivalent to K982421 (International Isotopes, Inc., 1998) and 3 other predicates after a 45-day review. Its family tree reaches back 2 generations to 1991.

Decided
Jun 17, 1999
Review
45 days
Class
Class II
Product code
KXK
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K914281 (1991). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1992: 1 other ancestorK914281 · I-125 Seeds, Code: 6711 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1991K982421 · Imagyn 125 I Seed, Model IS 125 · International Isotopes, Inc. · 1998199019921994199619982000
Other ancestors, by generation 1 generation back: 2 other ancestors K982421 · Imagyn 125 I Seed, Model IS 125 · International Isotopes, Inc. · 1998K914281 · I-125 Seeds, Code: 6711 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · 19910
  1. Root · 2 generations backK914281 I-125 Seeds, Code: 6711Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1991
  2. 1 generation backK982421 Imagyn 125 I Seed, Model IS 125International Isotopes, Inc. · 1998
  3. This deviceK991526 Isostar I-125 Interstitial Seed, Model IS-12501Imagyn Medical Technologies, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K914281I-125 Seeds, Code: 6711Medi-Physics Inc. Dba Nycomed Amersham Imaging1991—
−1K982421Imagyn 125 I Seed, Model IS 125International Isotopes, Inc.1998—
0 (this device)K991526Isostar I-125 Interstitial Seed, Model IS-12501Imagyn Medical Technologies, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199710
FIG. 1 — Lineage of K991526, 1991–1999Source: 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
*K982421Imagyn 125 I Seed, Model IS 125
Summary page 1
…Model IS-12501 Classification Name: Source, Radionuclide, Brachytherapy, 21 C.F.R. 892.5730 Predicate Devices: Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12500, K982421 EndoSeed, 510(k) number K914825/A Amersham Model 6711, K914281 Mentor 1oGOLD, K972271 Description of the Device: @fle Lo === P…
International Isotopes, Inc.1998—
*K9148251-125 Endoseed
Summary page 1
…me: Source, Radionuclide, Brachytherapy, 21 C.F.R. 892.5730 Predicate Devices: Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12500, K982421 EndoSeed, 510(k) number K914825/A Amersham Model 6711, K914281 Mentor 1oGOLD, K972271 Description of the Device: @fle Lo Mentor IoGOLD, K972271…
Endo Technic Corp.1992—
*K914281I-125 Seeds, Code: 6711
Summary page 1
…ytherapy, 21 C.F.R. 892.5730 Predicate Devices: Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12500, K982421 EndoSeed, 510(k) number K914825/A Amersham Model 6711, K914281 Mentor 1oGOLD, K972271 Description of the Device: @fle Lo Mentor IoGOLD, K972271 Iv. Description of the Device:…
Medi-Physics Inc. Dba Nycomed Amersham Imaging1991—
*K972271North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-a
Summary page 1
….5730 Predicate Devices: Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12500, K982421 EndoSeed, 510(k) number K914825/A Amersham Model 6711, K914281 Mentor 1oGOLD, K972271 Description of the Device: @fle Lo Mentor IoGOLD, K972271 Iv. Description of the Device: The Imagyn isoSTAR™ I-…
Ml Strategies, Inc.1997—

Also cleared against K982421: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
  • None of the 4 ancestors has a recall.
  • 1 other device also cites its predicate K982421.

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?

Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment for residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.

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 K982421

1 other device cites the same predicate.

  • K990193Iodine Brachytherapy Seeds, Model 3000Implant Sciences Corp. · 1999

More from Imagyn Medical Technologies, Inc.

7 FDA decisions under this applicant name. See the company

  • K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
  • K012706IM2001 Pulse OximeterImagyn Medical Technologies, Inc. · 2003
  • K010166Imagyn Isosleeve / Isostar Needle SystemImagyn Medical Technologies, Inc. · 2001
  • K980096Oac (Optical Aspirating Curette)Imagyn Medical Technologies, Inc. · 1998
  • K980291Impower External Vacuum SystemImagyn Medical Technologies, Inc. · 1998

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/K991526 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991526: Isostar I-125 Interstitial Seed, Model IS-12501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991526

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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