510(k) Report

510(k) · Cleared

Cleared

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

K032067510(k) TraditionalCleared Feb 10, 2004222-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 Feb 10, 2004 as substantially equivalent to K011690 (Proxima Therapeutics, Inc., 2002) and 3 other predicates after a 222-day review. Its family tree reaches back 5 generations to 1986. 9 later devices descend from it.

Decided
Feb 10, 2004
Review
222 days
Class
Class II
Product code
JAQ
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K864210 (1986). 9 ancestors in all, the oldest K853912 (1986). 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1986: 1 other ancestor2001: 1 other ancestor1993: 1 other ancestor2005: 1 descendant cleared2009: 1 descendant cleared2008: 1 descendant cleared2013: 2 descendants cleared2019: 2 descendants cleared2016: 1 descendant cleared2022: 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. · 2002K030558 · Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray · Proxima Therapeutics, Inc. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants K030558 · Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray · Proxima Therapeutics, Inc. · 2003K011690 · 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. · 1986−50+5
  1. Root · 5 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
  2. 4 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
  3. 3 generations backK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
  4. 2 generations backK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
  5. 1 generation backK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
  6. This deviceK032067 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2004
  7. Descendant · cites it directly · 8 of its ownK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005
  8. Descendant · 2 generations on · 5 of its ownK072683 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008
  9. Descendant · 3 generations on · 4 of its ownK122951 Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013
  10. Descendant · 4 generations on · 1 of its ownK153570 Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. · 2016
  11. Descendant · 4 generations on · 1 of its ownK132092 EsteyaNucletron B.V. · 2013

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12009: 12013: 22016: 12019: 22022: 1
2005high 2 (2013) · low 0 (2006)2026

Most influential descendants

Showing 5 of 9 · See all
  • K050843Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005 · cites it directly8descendants
  • K072683Axxent Electronic Brachytherapy SystemXoft, Inc. · 2008 · 2 generations on5descendants
  • K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc. · 2013 · 3 generations on4descendants
  • K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. · 2016 · 4 generations on1descendant
  • K132092EsteyaNucletron B.V. · 2013 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K864210Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp.1986—
−4K953946Microselectron-HDR Version 2Nucletron-Oldelft Corp.1996—
−3K983337Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp.1999—
−2K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2002—
−1K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2003—
0 (this device)K032067Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2004—
+1K050843Axxent Electronic Brachytherapy SystemXoft, Inc.2005—
+2K072683Axxent Electronic Brachytherapy SystemXoft, Inc.2008—
+3K122951Xoft Axxent Electronic Brachytherapy System Model 110Icad, Inc.2013—
+4K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc.2016—
+4K132092EsteyaNucletron B.V.2013—

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
200510
200810
200910
201320
201610
201920
202210
FIG. 1 — Lineage of K032067, 1986–2022Source: 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? (4)

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—
*K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray
Summary page 1
…ma Therapeutics, Inc. KO1 1690 Therapy System (RTS) MarrmoSite RTS - Proxima Therapeutics, Inc. K030558 5-6 cm Spherical I Afterloading Applicators Nucletron Corp.…
Proxima Therapeutics, Inc.2003—
*K853912Microselection Interstitial Remote Afterload Sys
Summary page 1
…Proxima Therapeutics, Inc. K030558 5-6 cm Spherical I Afterloading Applicators Nucletron Corp. K853912, K983341 Indications for The MammoSite RTS is an applicator intended to provide brachytherapy use when…
Nucletron-Oldelft Corp.1986—
*K983341Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set…
Summary page 1
…herapeutics, Inc. K030558 5-6 cm Spherical I Afterloading Applicators Nucletron Corp. K853912, K983341 Indications for The MammoSite RTS is an applicator intended to provide brachytherapy use when the phys…
Nucletron Corp.1999—

Also cleared against K011690: 6 other devices →

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050843Axxent Electronic Brachytherapy SystemXoft, Inc.20058

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, K050843 (Xoft, Inc., 2005) has gone furthest, with 8 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 MamrnoSite 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
  • K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2003

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
  • K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2003
  • 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

  • K262383LumenCare AzureNucletron B.V. · 2026
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  • K251037Rectal ApplicatorNucletron B.V. · 2025
  • K252884Guided Aarhus Applicator SetVarian Medical Systems · 2025
  • K250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc. · 2025

https://510kreport.com/device/K032067 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032067: 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/K032067

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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