510(k) · Cleared

Cleared

Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray

K041929510(k) SpecialCleared Aug 26, 200438-day reviewClass II21 CFR 892.5700

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

Proxima Therapeutics, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Aug 26, 2004 as substantially equivalent to K011690 (Proxima Therapeutics, Inc., 2002) and 1 other predicate after a 38-day review. Its family tree reaches back 5 generations to 1986. 17 later devices descend from it.

Decided: Aug 26, 2004
Review: 38 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K864210 (1986). 9 ancestors in all, the oldest K853912 (1986). 17 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
4 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
3 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
2 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
1 generation backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
This deviceK041929 Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
Descendant · cites it directly · 14 of its ownK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
Descendant · 2 generations on · 11 of its ownK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
Descendant · cites it directly · 9 of its ownK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
Descendant · 2 generations on · 8 of its ownK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
Descendant · 3 generations on · 5 of its ownK133655 Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2007high 3 (2008) · low 0 (2011)2026

Most influential descendants

Showing 5 of 17 · See all

K071229Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007 · cites it directly14descendants
K081079Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008 · 2 generations on11descendants
K091378Mammosite II Radiation Therapy SystemHologic, Inc. · 2009 · cites it directly9descendants
K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · 2 generations on8descendants
K133655Radiance V2Gmv Soluciones Globales Internet S.A.U. · 2014 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K864210	Microselectron-HDR (High Dose Rate)	Nucletron-Oldelft Corp.	1986	—
−4	K953946	Microselectron-HDR Version 2	Nucletron-Oldelft Corp.	1996	—
−3	K983337	Rotterdam Nasophayrnx Mould Set, Part #089.068	Nucletron Corp.	1999	—
−2	K011690	Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…	Proxima Therapeutics, Inc.	2002	—
−1	K030558	Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…	Proxima Therapeutics, Inc.	2003	—
0 (this device)	K041929	Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…	Proxima Therapeutics, Inc.	2004	—
+1	K071229	Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy	Senorx, Inc.	2007	—
+2	K081079	Contura MLB Source Applicator for Brachytherapy	Senorx, Inc.	2008	—
+1	K091378	Mammosite II Radiation Therapy System	Hologic, Inc.	2009	—
+2	K121653	Intrabeam System with Intrabeam Spherical Applicators	Carl Zeiss Meditec, Inc.	2012	2
+3	K133655	Radiance V2	Gmv Soluciones Globales Internet S.A.U.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1993	1	0
1999	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	3	0
2009	2	0
2010	1	0
2012	1	0
2013	1	0
2014	1	0
2016	2	0
2017	1	0
2018	1	0
2019	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K041929, 1986–2025Source: 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 JAQ? 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 JAQ device

#1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	K011690	Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray Summary page 1 …510(k) Number MammoSite Radiation Proxima Therapeutics, Inc. K01 1690 Therapy System (RTS) - 4-5 cm Spherical _ _…	Proxima Therapeutics, Inc.	2002	—
*	K030558	Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray Summary page 1 …_ _ _ MammoSite RTS - Proxima Therapeutics, Inc. K030558 5-6 cm Spherical _ _ _ _ _ _ _ _ _ _…	Proxima Therapeutics, Inc.	2003	—

Also cleared against K011690: 6 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K071229	Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy	Senorx, Inc.	2007	14
K091378	Mammosite II Radiation Therapy System	Hologic, Inc.	2009	9
K103215	Cianna S1, Single Lumen Balloon Applicator Kit	Cianna Medical	2010	0
K092405	Mammosite Multi Lumen	Hologic, Inc.	2009	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?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
None of the 9 ancestors has a recall.
Of its descendants, K071229 (Senorx, Inc., 2007) has gone furthest, with 14 descendants of its own.
6 other devices also cite its predicate K011690.

How does its category compare?

All JAQ devices

JAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAQ

6in 2025

2007high 11 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAQ

91in 2025

2007high 252 (2018) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAQ

1in 2019

2007high 13 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAQ

3in 2025

2007high 43 (2013) · low 1 (2024)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	48	0	13
2008	10	34	5	32
2009	10	27	1	35
2010	2	—	2	36
2011	2	—	13	42
2012	7	89	5	34
2013	6	100	1	43
2014	7	116	0	18
2015	11	183	0	7
2016	6	154	0	3
2017	7	229	0	5
2018	7	252	0	2
2019	2	—	1	8
2020	4	62	0	8
2021	0	—	0	5
2022	1	—	0	5
2023	2	—	0	3
2024	10	126	0	1
2025	6	91	0	3
2026	2	—	3	—

What is it indicated for?

The MammoSite RTS is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041929 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041929: Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041929

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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