510(k) · Cleared

Cleared

Imagyn 125 I Seed, Model IS 125

K982421510(k) SpecialCleared Jul 31, 199818-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

International Isotopes, Inc. · IWG Seed, Isotope, Gold, Titanium, Platinum

Cleared on Jul 31, 1998 as substantially equivalent to K914825 (Endo Technic Corp., 1992) and 2 other predicates after an 18-day review. Its family tree reaches back 1 generation to 1991. 6 later devices descend from it.

Decided: Jul 31, 1998
Review: 18 days
Class: Class II
Product code: IWG
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K914281 (1991). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK914281 I-125 Seeds, Code: 6711Medi-Physics Inc. Dba Nycomed Amersham Imaging · 1991
This deviceK982421 Imagyn 125 I Seed, Model IS 125International Isotopes, Inc. · 1998
Descendant · cites it directly · 4 of its ownK990193 Iodine Brachytherapy Seeds, Model 3000Implant Sciences Corp. · 1999
Descendant · 2 generations on · 2 of its ownK994317 I-Plant, Model 3500Implant Sciences Corp. · 2000
Descendant · 3 generations on · 1 of its ownK090366 Spec Model M-31Source Production & Equipment Co., Inc. · 2009
Descendant · 3 generations on · 0 of its ownK141038 Ant Model 1Advanced Nuclide Technologies, LLC · 2014
Descendant · 2 generations on · 0 of its ownK023242 I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-SterileImplant Sciences Corp. · 2002

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1999high 2 (1999) · low 0 (2001)2026

Most influential descendants

Showing 5 of 6 · See all

K990193Iodine Brachytherapy Seeds, Model 3000Implant Sciences Corp. · 1999 · cites it directly4descendants
K994317I-Plant, Model 3500Implant Sciences Corp. · 2000 · 2 generations on2descendants
K090366Spec Model M-31Source Production & Equipment Co., Inc. · 2009 · 3 generations on1descendant
K141038Ant Model 1Advanced Nuclide Technologies, LLC · 2014 · 3 generations on0descendants
K023242I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-SterileImplant Sciences Corp. · 2002 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914281	I-125 Seeds, Code: 6711	Medi-Physics Inc. Dba Nycomed Amersham Imaging	1991	—
0 (this device)	K982421	Imagyn 125 I Seed, Model IS 125	International Isotopes, Inc.	1998	—
+1	K990193	Iodine Brachytherapy Seeds, Model 3000	Implant Sciences Corp.	1999	—
+2	K994317	I-Plant, Model 3500	Implant Sciences Corp.	2000	—
+3	K090366	Spec Model M-31	Source Production & Equipment Co., Inc.	2009	—
+3	K141038	Ant Model 1	Advanced Nuclide Technologies, LLC	2014	—
+2	K023242	I-Plant Model 3500 (125IODINE Brachytherapy Seeds)-Sterile	Implant Sciences Corp.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0
2000	1	0
2002	1	0
2009	1	0
2014	1	0

FIG. 1 — Lineage of K982421, 1991–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K914825	1-125 Endoseed Summary page 1 …n Device Product Name: Imagyn "%l Seed Classification Name: . Source, Radionuclide, Brachytherapy, 21 C.F.R. § 892.5730 _ Predicate Devices: EndoSeed, 510(k) number K914825/A Amersham Model 6711, K914281 Mentor loGOLD, K972271 Imagyn '®I SEED International Isotopes, Inc. 7/10/98 Page 64 === Page 2…	Endo Technic Corp.	1992	—
*	K914281	I-125 Seeds, Code: 6711 Summary page 1 …"%l Seed Classification Name: . Source, Radionuclide, Brachytherapy, 21 C.F.R. § 892.5730 _ Predicate Devices: EndoSeed, 510(k) number K914825/A Amersham Model 6711, K914281 Mentor loGOLD, K972271 Imagyn '®I SEED International Isotopes, Inc. 7/10/98 Page 64 IV. Description of the Dev…	Medi-Physics Inc. Dba Nycomed Amersham Imaging	1991	—
*	K972271	North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-a Summary page 1 …Name: . Source, Radionuclide, Brachytherapy, 21 C.F.R. § 892.5730 _ Predicate Devices: EndoSeed, 510(k) number K914825/A Amersham Model 6711, K914281 Mentor loGOLD, K972271 Imagyn '®I SEED International Isotopes, Inc. 7/10/98 Page 64 IV. Description of the Device: The Imagyn 'l Seed…	Ml Strategies, Inc.	1997	—

Also cleared against K914825: 2 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K990193	Iodine Brachytherapy Seeds, Model 3000	Implant Sciences Corp.	1999	4
K991526	Isostar I-125 Interstitial Seed, Model IS-12501	Imagyn Medical Technologies, Inc.	1999	0

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?

None of the 3 ancestors has a recall.
Of its descendants, K990193 (Implant Sciences Corp., 1999) has gone furthest, with 4 descendants of its own.
2 other devices also cite its predicate K914825.

How does its category compare?

All IWG devices

IWG Seed, Isotope, Gold, Titanium, Platinum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IWG

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IWG

Too few IWG 510(k)s in any year since 2007 to give a median.

Recalls per year · IWG

No recall names IWG since 2007.

Adverse event reports per year · IWG

1in 2010

2007high 1 (2008) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	1
2009	0	—	0
2010	0	—	1
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Imagyn®I Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can to 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.

https://510kreport.com/device/K982421 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982421: Imagyn 125 I Seed, Model IS 125.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982421

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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