510(k) Report

510(k) · Cleared

Cleared

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

K030558510(k) TraditionalCleared May 21, 200389-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 21, 2003 as substantially equivalent to K011690 (Proxima Therapeutics, Inc., 2002) after an 89-day review. Its family tree reaches back 4 generations to 1986. 33 later devices descend from it.

Decided
May 21, 2003
Review
89 days
Class
Class II
Product code
JAQ
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K864210 (1986). 8 ancestors in all, the oldest K853912 (1986). 33 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 1 other ancestor1986: 1 other ancestor1993: 1 other ancestor2004: 2 descendants cleared2005: 2 descendants cleared2008: 5 descendants cleared2007: 1 descendant cleared2010: 2 descendants cleared2009: 4 descendants cleared2006: 1 descendant cleared2013: 3 descendants cleared2019: 3 descendants cleared2012: 1 descendant cleared2025: 1 descendant cleared2014: 1 descendant cleared2016: 3 descendants cleared2022: 1 descendant cleared2017: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant clearedK864210 · Microselectron-HDR (High Dose Rate) · Nucletron-Oldelft Corp. · 1986K953946 · Microselectron-HDR Version 2 · Nucletron-Oldelft Corp. · 1996K983337 · Rotterdam Nasophayrnx Mould Set, Part #089.068 · Nucletron Corp. · 1999K011690 · Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray · Proxima Therapeutics, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 10 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 3 descendants K011690 · Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray · Proxima Therapeutics, Inc. · 2002K983337 · Rotterdam Nasophayrnx Mould Set, Part #089.068 · Nucletron Corp. · 1999K953946 · Microselectron-HDR Version 2 · Nucletron-Oldelft Corp. · 1996K864210 · Microselectron-HDR (High Dose Rate) · Nucletron-Oldelft Corp. · 19860+5
  1. Root · 4 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
  2. 3 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
  3. 2 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
  4. 1 generation backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
  5. This deviceK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
  6. Descendant · cites it directly · 17 of its ownK041929 Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
  7. Descendant · 2 generations on · 14 of its ownK071229 Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc. · 2007
  8. Descendant · cites it directly · 11 of its ownK081079 Contura MLB Source Applicator for BrachytherapySenorx, Inc. · 2008
  9. Descendant · 2 generations on · 9 of its ownK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
  10. Descendant · cites it directly · 9 of its ownK032067 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2004: 22005: 22006: 12007: 12008: 52009: 42010: 22012: 12013: 32014: 12016: 32017: 12018: 12019: 32022: 12024: 12025: 1
2004high 5 (2008) · low 0 (2011)2026

Most influential descendants

Showing 5 of 33 · See all
  • 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 · cites it directly11descendants
  • K091378Mammosite II Radiation Therapy SystemHologic, Inc. · 2009 · 2 generations on9descendants
  • K032067Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2004 · cites it directly9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K864210Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp.1986—
−3K953946Microselectron-HDR Version 2Nucletron-Oldelft Corp.1996—
−2K983337Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp.1999—
−1K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2002—
0 (this device)K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2003—
+1K041929Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2004—
+2K071229Senorad Multi-Lumen Balloon Source Applicator for BranchytherapySenorx, Inc.2007—
+1K081079Contura MLB Source Applicator for BrachytherapySenorx, Inc.2008—
+2K091378Mammosite II Radiation Therapy SystemHologic, Inc.2009—
+1K032067Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199310
199910
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200520
200610
200710
200850
200940
201020
201210
201330
201410
201630
201710
201810
201930
202210
202410
202510
FIG. 1 — Lineage of K030558, 1986–2025Source: 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 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. #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 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? (1)

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
*K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.2002—

Also cleared against K011690: 6 other devices →

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K041929Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories…Proxima Therapeutics, Inc.200417
K081079Contura MLB Source Applicator for BrachytherapySenorx, Inc.200811
K032067Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.20049
K050843Axxent Electronic Brachytherapy SystemXoft, Inc.20058
K081179Mammosite Cavity Evaluation DeviceHologic, Inc.20082
K052351HDR Iort Shielded ApplicatorMick Radio-Nuclear Instruments, Inc.20051

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 17 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K041929 (Proxima Therapeutics, Inc., 2004) has gone furthest, with 17 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

2007: 112008: 102009: 102010: 22011: 22012: 72013: 62014: 72015: 112016: 62017: 72018: 72019: 22020: 42022: 12023: 22024: 102025: 62026 (partial year): 2
2007high 11 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAQ

91in 2025

2007: 48 days median2008: 34 days median2009: 27 days median2012: 89 days median2013: 100 days median2014: 116 days median2015: 183 days median2016: 154 days median2017: 229 days median2018: 252 days median2020: 62 days median2024: 126 days median2025: 91 days median
2007high 252 (2018) · low 27 (2009)2026

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

Recalls per year · JAQ

1in 2019

2008: 52009: 12010: 22011: 132012: 52013: 12019: 12026 (partial year): 3
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

2007: 132008: 322009: 352010: 362011: 422012: 342013: 432014: 182015: 72016: 32017: 52018: 22019: 82020: 82021: 52022: 52023: 32024: 12025: 3
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071148013
20081034532
20091027135
20102—236
20112—1342
2012789534
20136100143
20147116018
20151118307
2016615403
2017722905
2018725202
20192—18
202046208
20210—05
20221—05
20232—03
20241012601
202569103
20262—3—

What is it indicated for?

The MammoSite 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.

Also cleared against K011690

6 other devices cite the same predicate.

  • K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 20122 recalls
  • K081179Mammosite Cavity Evaluation DeviceHologic, Inc. · 2008
  • K050843Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
  • K052351HDR Iort Shielded ApplicatorMick Radio-Nuclear Instruments, Inc. · 2005
  • K041929Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2004
  • K032067Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2004

More from Proxima Therapeutics, Inc.

5 FDA decisions under this applicant name. See the company

  • K041929Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2004
  • K032067Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2004
  • K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2002
  • K003206Gliasite Radiation Therapy System (RTS), Model 1020,1030,1040,8150,9005Proxima Therapeutics, Inc. · 2001

Recent decisions in JAQ

The JAQ category page

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https://510kreport.com/device/K030558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030558: 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 6, 2026. https://510kreport.com/device/K030558

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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