510(k) Report

510(k) · Cleared

Cleared

Theraplan Plus

K954679510(k) TraditionalCleared Nov 8, 1996395-day reviewClass II21 CFR 892.5050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Theratronics, Inc. · IYE Accelerator, Linear, Medical

Cleared on Nov 8, 1996 after a 395-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 66 later devices descend from it.

Decided
Nov 8, 1996
Review
395 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2003: 2 descendants cleared1999: 1 descendant cleared1998: 2 descendants cleared2008: 2 descendants cleared2007: 1 descendant cleared2000: 1 descendant cleared2009: 3 descendants cleared2012: 3 descendants cleared2010: 4 descendants cleared2011: 1 descendant cleared2013: 3 descendants cleared2014: 4 descendants cleared2020: 3 descendants cleared2015: 3 descendants cleared2016: 3 descendants cleared2017: 5 descendants cleared2018: 5 descendants cleared2023: 3 descendants cleared2019: 4 descendants cleared2024: 2 descendants cleared2021: 3 descendants cleared2022: 4 descendants cleared2026: 1 descendant cleared2025: 2 descendants cleared1995200020052010201520202025
  1. This deviceK954679 Theraplan PlusTheratronics, Inc. · 1996
  2. Descendant · cites it directly · 65 of its ownK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
  3. Descendant · 2 generations on · 59 of its ownK031349 OTP 1.2Nucletron Corp. · 2003
  4. Descendant · 3 generations on · 54 of its ownK081281 Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · Recalled
  5. Descendant · 4 generations on · 34 of its ownK092132 Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · Recalled
  6. Descendant · 4 generations on · 31 of its ownK083264 Rayautoplan 1.0Raysearch Laboratories AB · 2009 · Recalled

Showing 5 of 66 descendants. See all descendants

Descendants cleared per year

1997: 11998: 21999: 12000: 12003: 22007: 12008: 22009: 32010: 42011: 12012: 32013: 32014: 42015: 32016: 32017: 52018: 52019: 42020: 32021: 32022: 42023: 32024: 22025: 22026: 1
1997high 5 (2017) · low 0 (2001)2026

Most influential descendants

Showing 5 of 66 · See all
  • K970236Theraplan Plus Version 1.2Theratronics, Inc. · 1997 · cites it directly65descendants
  • K031349OTP 1.2Nucletron Corp. · 2003 · 2 generations on59descendants
  • K081281Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · 3 generations on54descendants
  • K092132Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · 4 generations on34descendants
  • K083264Rayautoplan 1.0Raysearch Laboratories AB · 2009 · 4 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954679Theraplan PlusTheratronics, Inc.1996—
+1K970236Theraplan Plus Version 1.2Theratronics, Inc.1997—
+2K031349OTP 1.2Nucletron Corp.2003—
+3K081281Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation20082
+4K092132Xio RTP SystemComputerized Medical Systems, Inc.200912
+4K083264Rayautoplan 1.0Raysearch Laboratories AB20092

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
199910
200010
200320
200710
200820
200930
201040
201110
201230
201330
201440
201530
201630
201750
201850
201940
202030
202130
202240
202330
202420
202520
202610
FIG. 1 — Lineage of K954679, 1996–2026Source: 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 IYE? 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 IYE device

  1. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (66)

See all 66

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

NumberDeviceApplicantDecidedDescendants
K970236Theraplan Plus Version 1.2Theratronics, Inc.199765

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, K970236 (Theratronics, Inc., 1997) has gone furthest, with 65 descendants of its own.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

More from Theratronics, Inc.

9 FDA decisions under this applicant name. See the company

  • K983917Theratron EliteTheratronics, Inc. · 19982 recalls
  • K970236Theraplan Plus Version 1.2Theratronics, Inc. · 1997
  • K964606Theratron 780ETheratronics, Inc. · 19971 recall
  • K964607Theraton 1000ETheratronics, Inc. · 19971 recall
  • K940237Theraplan V05B/ TP-11 V09BTheratronics, Inc. · 1994

Recent decisions in IYE

The IYE category page

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  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K954679 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954679: Theraplan Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954679

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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