510(k) · Cleared

Cleared

I-125 Rapid Strand

K940632510(k) TraditionalCleared Sep 2, 1994200-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 · IWI Source, Isotope, Sealed, Gold, Titanium, Platinum

Cleared on Sep 2, 1994 after a 200-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 53 later devices descend from it.

Decided: Sep 2, 1994
Review: 200 days
Class: Class II
Product code: IWI
Recalls: None
Predicates: 0

53 later devices descend from it, 7 citing it directly.

This deviceK940632 I-125 Rapid StrandMedi-Physics Inc. Dba Nycomed Amersham Imaging · 1994
Descendant · cites it directly · 26 of its ownK001070 Radiomed SourceRadiomed Corp. · 2000
Descendant · 2 generations on · 23 of its ownK013660 GenetraRadiomed Corporation · 2001
Descendant · 3 generations on · 21 of its ownK022326 Radiomed MarkerRadiomed Corporation · 2003
Descendant · 4 generations on · 20 of its ownK031206 Radiomed Soft Tissue MarkerRadiomed Corp. · 2003
Descendant · cites it directly · 17 of its ownK030594 I-125 Rapid Strand, Model 7000Amersham Health · 2003

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

1999high 7 (2012) · low 0 (2021)2026

Most influential descendants

Showing 5 of 53 · See all

K001070Radiomed SourceRadiomed Corp. · 2000 · cites it directly26descendants
K013660GenetraRadiomed Corporation · 2001 · 2 generations on23descendants
K022326Radiomed MarkerRadiomed Corporation · 2003 · 3 generations on21descendants
K031206Radiomed Soft Tissue MarkerRadiomed Corp. · 2003 · 4 generations on20descendants
K030594I-125 Rapid Strand, Model 7000Amersham Health · 2003 · cites it directly17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940632	I-125 Rapid Strand	Medi-Physics Inc. Dba Nycomed Amersham Imaging	1994	—
+1	K001070	Radiomed Source	Radiomed Corp.	2000	—
+2	K013660	Genetra	Radiomed Corporation	2001	—
+3	K022326	Radiomed Marker	Radiomed Corporation	2003	—
+4	K031206	Radiomed Soft Tissue Marker	Radiomed Corp.	2003	—
+1	K030594	I-125 Rapid Strand, Model 7000	Amersham Health	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	1	0
2001	1	0
2002	2	0
2003	4	0
2004	2	0
2005	1	0
2006	4	0
2007	3	0
2008	2	0
2009	4	0
2010	1	0
2011	2	0
2012	7	0
2013	1	0
2014	3	0
2015	1	0
2016	1	0
2017	3	0
2018	2	0
2019	1	0
2020	3	0
2022	2	0
2025	1	0

FIG. 1 — Lineage of K940632, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 IWI? 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

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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? (53)

See all 53

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

Number	Device	Applicant	Decided	Descendants
K001070	Radiomed Source	Radiomed Corp.	2000	26
K030594	I-125 Rapid Strand, Model 7000	Amersham Health	2003	17
K013975	CP-Sleeve	Cp Medical	2002	6
K063177	Rapid Strand RX	Oncura, Inc.	2006	1
K023073	Seed Link	Implant Sciences Corp.	2003	1
K061638	Best Strand and Best Spacer	Best Medical International, Inc.	2006	0
K992262	Indigo Prostate Seeding Needle Cartridge System	Indigo Medical, 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?

Of its descendants, K001070 (Radiomed Corp., 2000) has gone furthest, with 26 descendants of its own.

How does its category compare?

All IWI devices

IWI Source, Isotope, Sealed, Gold, Titanium, Platinum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IWI

FDA has decided no IWI device since 2007.

Median 510(k) review, days · IWI

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

Recalls per year · IWI

No recall names IWI since 2007.

Adverse event reports per year · IWI

1in 2015

2007high 2 (2013) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	2
2014	—	0
2015	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K940632 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940632: I-125 Rapid Strand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940632

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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