510(k) Report

510(k) · Cleared

Cleared

Microselectron-HDR Version 2

K953946510(k) TraditionalCleared Aug 13, 1996358-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

Nucletron-Oldelft Corp. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Aug 13, 1996 as substantially equivalent to K864210 (Nucletron-Oldelft Corp., 1986) and 1 other predicate after a 358-day review. Its family tree reaches back 1 generation to 1986. 106 later devices descend from it.

Decided
Aug 13, 1996
Review
358 days
Class
Class II
Product code
JAQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K864210 (1986). 2 ancestors in all. 106 later devices descend from it, 28 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor2002: 5 descendants cleared2015: 5 descendants cleared2005: 7 descendants cleared2017: 3 descendants cleared2011: 3 descendants cleared2009: 10 descendants cleared2007: 5 descendants cleared2004: 3 descendants cleared2008: 10 descendants cleared2006: 8 descendants cleared1999: 4 descendants cleared2001: 1 descendant cleared2014: 5 descendants cleared2013: 5 descendants cleared2003: 3 descendants cleared2012: 4 descendants cleared2020: 2 descendants cleared2016: 5 descendants cleared2025: 4 descendants cleared2023: 2 descendants cleared2010: 2 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2019: 4 descendants cleared2024: 1 descendant clearedK864210 · Microselectron-HDR (High Dose Rate) · Nucletron-Oldelft Corp. · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 28 descendants2 generations forward: 33 descendants3 generations forward: 27 descendants4 generations forward: 9 descendants5 generations forward: 4 descendants6 generations forward: 5 descendants K864210 · Microselectron-HDR (High Dose Rate) · Nucletron-Oldelft Corp. · 19860+5
  1. Root · 1 generation backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
  2. This deviceK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
  3. Descendant · cites it directly · 42 of its ownK983341 Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal…Nucletron Corp. · 1999
  4. Descendant · cites it directly · 36 of its ownK983337 Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999
  5. Descendant · cites it directly · 34 of its ownK011690 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2002
  6. Descendant · 2 generations on · 33 of its ownK030558 Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR…Proxima Therapeutics, Inc. · 2003
  7. Descendant · cites it directly · 20 of its ownK020015 Implant Guidance System Applicator SetNucletron Corp. · 2002

Showing 5 of 106 descendants. See all descendants

Descendants cleared per year

1999: 42001: 12002: 52003: 32004: 32005: 72006: 82007: 52008: 102009: 102010: 22011: 32012: 42013: 52014: 52015: 52016: 52017: 32018: 32019: 42020: 22022: 22023: 22024: 12025: 4
1999high 10 (2008) · low 0 (2000)2026

Most influential descendants

Showing 5 of 106 · See all
  • K983341Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set…Nucletron Corp. · 1999 · cites it directly42descendants
  • K983337Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999 · cites it directly36descendants
  • K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2002 · cites it directly34descendants
  • K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2003 · 2 generations on33descendants
  • K020015Implant Guidance System Applicator SetNucletron Corp. · 2002 · cites it directly20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K864210Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp.1986—
0 (this device)K953946Microselectron-HDR Version 2Nucletron-Oldelft Corp.1996—
+1K983341Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR…Nucletron Corp.1999—
+1K983337Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp.1999—
+1K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2002—
+2K030558Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader…Proxima Therapeutics, Inc.2003—
+1K020015Implant Guidance System Applicator SetNucletron Corp.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199940
200110
200250
200330
200430
200570
200680
200750
2008100
2009100
201020
201130
201240
201350
201450
201550
201650
201730
201830
201940
202020
202220
202320
202410
202540
FIG. 1 — Lineage of K953946, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K864210Microselectron-HDR (High Dose Rate)
Summary page 2
…gulatory Affairs Director Phone: 410-872-4444 FAX: 410-312-4197 Prepared: July 19, 1995 Device Name microSelectron HDR version 2 Predicate Device microSelectron HDR (K864210) microSelectron HDR for Mobile Environment (K925956) Description: The microSetectron HOR version 2 is an improvement over its p…
Nucletron-Oldelft Corp.1986—
*K925956Microselectron - HDR for Mobile Environment
Summary page 2
…10-312-4197 Prepared: July 19, 1995 Device Name microSelectron HDR version 2 Predicate Device microSelectron HDR (K864210) microSelectron HDR for Mobile Environment (K925956) Description: The microSetectron HOR version 2 is an improvement over its predicate device, primarily in the areas of ergonomic…
Nucletron-Oldelft Corp.1993—

Also cleared against K864210: 3 other devices →

What descends from it? (106)

See all 106

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

NumberDeviceApplicantDecidedDescendants
K983341Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set…Nucletron Corp.199942
K983337Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp.199936
K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.200234
K020015Implant Guidance System Applicator SetNucletron Corp.200220
K992577Photon Radiosurgery System (PRS)Photoelectron Corporation199920
K011657HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc.200113
K041933Microselectron PDRNucletron Corp.20048
K073107Valencia Skin Applicator Set, Model: 189.701Nucletron Corporation20077
K042864Implant Sciences Corp, Model HDR-4140Implant Sciences Corp.20054
K092822Capri ApplicatorVivaray, Inc.20092

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K983341 (Nucletron Corp., 1999) has gone furthest, with 42 descendants of its own.
  • 3 other devices also cite its predicate K864210.

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—

Also cleared against K864210

3 other devices cite the same predicate.

  • K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc. · 2002
  • K99157110 Curie Irdium 192, CSN00100-192Alpha-Omega Services, Inc. · 2000
  • K983115Treatment Control Station - Microselectron-HDR Classic Upgrade, Version 1.20Nucletron Corp. · 1999

More from Nucletron-Oldelft Corp.

11 FDA decisions under this applicant name. See the company

  • K953831N 800 HFNucletron-Oldelft Corp. · 1995
  • K925956Microselectron - HDR for Mobile EnvironmentNucletron-Oldelft Corp. · 1993
  • K926407Model Cole Tab-2 Table W/Model Cole SFD-2 SpotfilmNucletron-Oldelft Corp. · 1993
  • K921991Plato Radiation Therapy Planning SystemNucletron-Oldelft Corp. · 1992
  • K915622Plato Brachytheraphy Treatment Planning SystemNucletron-Oldelft Corp. · 1992

Recent decisions in JAQ

The JAQ category page

  • K262383LumenCare AzureNucletron B.V. · 2026
  • K252717MAASTRO Rectal Applicator SetVarian Medical Systems · 2026
  • 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/K953946 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953946: Microselectron-HDR Version 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953946

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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