510(k) Report

510(k) · Cleared

Cleared

Microselectron-HDR (High Dose Rate)

K864210510(k) TraditionalCleared Nov 26, 198629-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 Nov 26, 1986 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 112 later devices descend from it.

Decided
Nov 26, 1986
Review
29 days
Class
Class II
Product code
JAQ
Recalls
None
Predicates
0

112 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2002: 5 descendants cleared1996: 1 descendant cleared1999: 4 descendants cleared2012: 4 descendants cleared2004: 3 descendants cleared2005: 7 descendants cleared2008: 10 descendants cleared2003: 3 descendants cleared2015: 6 descendants cleared2017: 3 descendants cleared2011: 3 descendants cleared2009: 10 descendants cleared2007: 5 descendants cleared2006: 8 descendants cleared2001: 1 descendant cleared2014: 6 descendants cleared2013: 5 descendants cleared2020: 2 descendants cleared2016: 7 descendants cleared2025: 4 descendants cleared2010: 2 descendants cleared2023: 2 descendants cleared2019: 4 descendants cleared2018: 3 descendants cleared2022: 2 descendants cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
  2. Descendant · cites it directly · 106 of its ownK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
  3. Descendant · 2 generations on · 42 of its ownK983341 Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal…Nucletron Corp. · 1999
  4. Descendant · 2 generations on · 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

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

1996: 11999: 42000: 12001: 12002: 52003: 32004: 32005: 72006: 82007: 52008: 102009: 102010: 22011: 32012: 42013: 52014: 62015: 62016: 72017: 32018: 32019: 42020: 22022: 22023: 22024: 12025: 4
1996high 10 (2008) · low 0 (1997)2026

Most influential descendants

Showing 5 of 112 · See all
  • K953946Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996 · cites it directly106descendants
  • K983341Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set…Nucletron Corp. · 1999 · 2 generations on42descendants
  • K983337Rotterdam Nasophayrnx Mould Set, Part #089.068Nucletron Corp. · 1999 · 2 generations on36descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864210Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp.1986—
+1K953946Microselectron-HDR Version 2Nucletron-Oldelft Corp.1996—
+2K983341Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR…Nucletron Corp.1999—
+2K983337Rotterdam 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199940
200010
200110
200250
200330
200430
200570
200680
200750
2008100
2009100
201020
201130
201240
201350
201460
201560
201670
201730
201830
201940
202020
202220
202320
202410
202540
FIG. 1 — Lineage of K864210, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (112)

See all 112

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

NumberDeviceApplicantDecidedDescendants
K953946Microselectron-HDR Version 2Nucletron-Oldelft Corp.1996106
K011690Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayProxima Therapeutics, Inc.200234
K99157110 Curie Irdium 192, CSN00100-192Alpha-Omega Services, Inc.200011
K983115Treatment Control Station - Microselectron-HDR Classic Upgrade, Version 1.20Nucletron Corp.19990

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?

  • Of its descendants, K953946 (Nucletron-Oldelft Corp., 1996) has gone furthest, with 106 descendants of its own.

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—

More from Nucletron-Oldelft Corp.

11 FDA decisions under this applicant name. See the company

  • K953946Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
  • 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

Recent decisions in JAQ

The JAQ category page

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  • K251037Rectal ApplicatorNucletron B.V. · 2025
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  • K250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc. · 2025

https://510kreport.com/device/K864210 · printed Nov 4, 2026

Cite this page

510(k) Report. “K864210: Microselectron-HDR (High Dose Rate).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864210

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026