510(k) · Decided

Decided

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

K011690510(k) TraditionalDecided May 6, 2002340-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 May 6, 2002 as substantially equivalent to K003206 (Proxima Therapeutics, Inc., 2001) and 5 other predicates after a 340-day review. Its family tree reaches back 3 generations to 1986. 34 later devices descend from it.

Decided: May 6, 2002
Review: 340 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 6

Its longest line of descent runs back 3 generations to K864210 (1986). 7 ancestors in all, the oldest K853912 (1986). 34 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 3 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
2 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
1 generation backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
This deviceK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
Descendant · cites it directly · 33 of its ownK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
Descendant · cites it directly · 17 of its ownK041929 Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
Descendant · 2 generations on · 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 · 2 generations on · 9 of its ownK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2003high 5 (2008) · low 0 (2011)2026

Most influential descendants

Showing 5 of 34 · See all

K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2003 · cites it directly33descendants
K041929Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories…Proxima Therapeutics, Inc. · 2004 · cites it directly17descendants
K071229Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007 · 2 generations on14descendants
K081079Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008 · 2 generations on11descendants
K091378Mammosite II Radiation Therapy SystemHologic, Inc. · 2009 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K864210	Microselectron-HDR (High Dose Rate)	Nucletron-Oldelft Corp.	1986	—
−2	K953946	Microselectron-HDR Version 2	Nucletron-Oldelft Corp.	1996	—
−1	K983337	Rotterdam Nasophayrnx Mould Set, Part #089.068	Nucletron Corp.	1999	—
0 (this device)	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	—
+1	K041929	Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…	Proxima Therapeutics, Inc.	2004	—
+2	K071229	Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy	Senorx, Inc.	2007	—
+2	K081079	Contura MLB Source Applicator for Brachytherapy	Senorx, Inc.	2008	—
+2	K091378	Mammosite II Radiation Therapy System	Hologic, Inc.	2009	—

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
2003	1	0
2004	2	0
2005	2	0
2006	1	0
2007	1	0
2008	5	0
2009	4	0
2010	2	0
2012	1	0
2013	3	0
2014	1	0
2016	3	0
2017	1	0
2018	1	0
2019	3	0
2022	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K011690, 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? (6)

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
*	K003206	Gliasite Radiation Therapy System (RTS), Model 1020,1030,1040,8150,9005 Summary page 1 …ing lumpectomy for breast cancer. 4. Predicate Devices The MammoSite RTS is substantially equivalent to Proxima Therapeutics, Inc.'s GliaSite Radiation Therapy System (K003206) and Nucletron Corporation radionuclide applicator systems (K853912, K864210, K953946, K983337, K983341) in terms of its technica…	Proxima Therapeutics, Inc.	2001	—
*	K853912	Microselection Interstitial Remote Afterload Sys Summary page 1 …te RTS is substantially equivalent to Proxima Therapeutics, Inc.'s GliaSite Radiation Therapy System (K003206) and Nucletron Corporation radionuclide applicator systems (K853912, K864210, K953946, K983337, K983341) in terms of its technical specifications, intended use and method of application. 5. Compar…	Nucletron-Oldelft Corp.	1986	—
*	K864210	Microselectron-HDR (High Dose Rate) Summary page 1 …substantially equivalent to Proxima Therapeutics, Inc.'s GliaSite Radiation Therapy System (K003206) and Nucletron Corporation radionuclide applicator systems (K853912, K864210, K953946, K983337, K983341) in terms of its technical specifications, intended use and method of application. 5. Comparison of T…	Nucletron-Oldelft Corp.	1986	—
*	K953946	Microselectron-HDR Version 2 Summary page 1 …ially equivalent to Proxima Therapeutics, Inc.'s GliaSite Radiation Therapy System (K003206) and Nucletron Corporation radionuclide applicator systems (K853912, K864210, K953946, K983337, K983341) in terms of its technical specifications, intended use and method of application. 5. Comparison of Technologi…	Nucletron-Oldelft Corp.	1996	—
*	K983337	Rotterdam Nasophayrnx Mould Set, Part #089.068 Summary page 1 …ivalent to Proxima Therapeutics, Inc.'s GliaSite Radiation Therapy System (K003206) and Nucletron Corporation radionuclide applicator systems (K853912, K864210, K953946, K983337, K983341) in terms of its technical specifications, intended use and method of application. 5. Comparison of Technological Chara…	Nucletron Corp.	1999	—
*	K983341	Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set… Summary page 1 …o Proxima Therapeutics, Inc.'s GliaSite Radiation Therapy System (K003206) and Nucletron Corporation radionuclide applicator systems (K853912, K864210, K953946, K983337, K983341) in terms of its technical specifications, intended use and method of application. 5. Comparison of Technological Characteristic…	Nucletron Corp.	1999	—

Also cleared against K003206: 1 other device →

What descends from it? (34)

See all 34

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

Number	Device	Applicant	Decided	Descendants
K030558	Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray	Proxima Therapeutics, Inc.	2003	33
K041929	Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories…	Proxima Therapeutics, Inc.	2004	17
K032067	Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray	Proxima Therapeutics, Inc.	2004	9
K121653	Intrabeam System with Intrabeam Spherical Applicators	Carl Zeiss Meditec, Inc.	2012	8
K050843	Axxent Electronic Brachytherapy System	Xoft, Inc.	2005	8
K081179	Mammosite Cavity Evaluation Device	Hologic, Inc.	2008	2
K052351	HDR Iort Shielded Applicator	Mick Radio-Nuclear Instruments, Inc.	2005	1

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 16 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K030558 (Proxima Therapeutics, Inc., 2003) has gone furthest, with 33 descendants of its own.
1 other device also cites its predicate K003206.

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 Radiation Therapy System 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K011690 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011690: Mammosite 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 4, 2026. https://510kreport.com/device/K011690

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026