510(k) · Cleared

Cleared

Selectron HDR Remote Afterloader

K852842510(k) TraditionalCleared Jan 10, 1986189-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 Jan 10, 1986 after a 189-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.

Decided: Jan 10, 1986
Review: 189 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 0

32 later devices descend from it, 1 citing it directly.

This deviceK852842 Selectron HDR Remote AfterloaderNucletron-Oldelft Corp. · 1986
Descendant · cites it directly · 31 of its ownK963258 Peacock SystemNomos Corp. · 1996
Descendant · 2 generations on · 24 of its ownK993766 Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999
Descendant · 3 generations on · 23 of its ownK010682 Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001
Descendant · 4 generations on · 22 of its ownK020971 DCM 2.0Mds Nordion AB · 2002
Descendant · 5 generations on · 21 of its ownK130617 RaystationRaysearch Laboratories AB · 2013 · Recalled

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

1996high 4 (2021) · low 0 (1997)2026

Most influential descendants

Showing 5 of 32 · See all

K963258Peacock SystemNomos Corp. · 1996 · cites it directly31descendants
K993766Helax-TMS V 5.0 Radiation Therapy Treatment Planning SystemHelax AB · 1999 · 2 generations on24descendants
K010682Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001 · 3 generations on23descendants
K020971DCM 2.0Mds Nordion AB · 2002 · 4 generations on22descendants
K130617RaystationRaysearch Laboratories AB · 2013 · 5 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K852842	Selectron HDR Remote Afterloader	Nucletron-Oldelft Corp.	1986	—
+1	K963258	Peacock System	Nomos Corp.	1996	—
+2	K993766	Helax-TMS V 5.0 Radiation Therapy Treatment Planning System	Helax AB	1999	—
+3	K010682	Helax-TMS V 5.1 Radiation Therapy Treatment Planning System	Mds Nordion	2001	—
+4	K020971	DCM 2.0	Mds Nordion AB	2002	—
+5	K130617	Raystation	Raysearch Laboratories AB	2013	6

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	2	0
2001	1	0
2002	1	0
2003	1	0
2010	1	0
2013	1	0
2014	2	0
2015	2	0
2016	1	0
2017	3	0
2018	2	0
2019	1	0
2020	2	0
2021	4	0
2022	2	0
2023	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K852842, 1986–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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?

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

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K963258	Peacock System	Nomos Corp.	1996	31

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, K963258 (Nomos Corp., 1996) has gone furthest, with 31 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

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	—

https://510kreport.com/device/K852842 · printed Nov 5, 2026

Cite this page

510(k) Report. “K852842: Selectron HDR Remote Afterloader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K852842

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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