510(k) Report

510(k) · Cleared

Cleared

Model 35300 Tracker (TM) Therapy Beam Evaluator

K874893510(k) TraditionalCleared Feb 17, 198878-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

Keithley Instruments, Inc. · IYE Accelerator, Linear, Medical

Cleared on Feb 17, 1988 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.

Decided
Feb 17, 1988
Review
78 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
0

36 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2006: 1 descendant cleared2007: 1 descendant cleared2016: 6 descendants cleared2014: 2 descendants cleared2013: 1 descendant cleared2018: 2 descendants cleared2015: 1 descendant cleared2017: 3 descendants cleared2026: 3 descendants cleared2020: 1 descendant cleared2019: 2 descendants cleared2022: 3 descendants cleared2024: 2 descendants cleared2021: 1 descendant cleared2023: 2 descendants cleared2025: 3 descendants cleared1990200020102020
  1. This deviceK874893 Model 35300 Tracker (TM) Therapy Beam EvaluatorKeithley Instruments, Inc. · 1988
  2. Descendant · cites it directly · 34 of its ownK972211 Multidos, QC6PLUSPtw-New York Corp. · 1997
  3. Descendant · 2 generations on · 33 of its ownK062817 PTW David Imrt QC Verification SystemPtw-New York Corp. · 2006
  4. Descendant · 3 generations on · 31 of its ownK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
  5. Descendant · 4 generations on · 23 of its ownK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
  6. Descendant · 5 generations on · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

1997: 22006: 12007: 12013: 12014: 22015: 12016: 62017: 32018: 22019: 22020: 12021: 12022: 32023: 22024: 22025: 32026: 3
1997high 6 (2016) · low 0 (1998)2026

Most influential descendants

Showing 5 of 36 · See all
  • K972211Multidos, QC6PLUSPtw-New York Corp. · 1997 · cites it directly34descendants
  • K062817PTW David Imrt QC Verification SystemPtw-New York Corp. · 2006 · 2 generations on33descendants
  • K072374CompassScanditronix Wellhofer GmbH · 2007 · 3 generations on31descendants
  • K140660MOBIUS3DMobius Medical Systems, LP · 2014 · 4 generations on23descendants
  • K153014Mobius3DMobius Medical Systems, LP · 2016 · 5 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874893Model 35300 Tracker (TM) Therapy Beam EvaluatorKeithley Instruments, Inc.1988—
+1K972211Multidos, QC6PLUSPtw-New York Corp.1997—
+2K062817PTW David Imrt QC Verification SystemPtw-New York Corp.2006—
+3K072374CompassScanditronix Wellhofer GmbH20073
+4K140660MOBIUS3DMobius Medical Systems, LP20141
+5K153014Mobius3DMobius Medical Systems, LP2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
200610
200710
201310
201420
201510
201660
201730
201820
201920
202010
202110
202230
202320
202420
202530
202630
FIG. 1 — Lineage of K874893, 1988–2026Source: 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? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K972211Multidos, QC6PLUSPtw-New York Corp.199734
K970384Velos Constancy Check Device, Model 55-145Aktina Medical Physics Corp.19970

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, K972211 (Ptw-New York Corp., 1997) has gone furthest, with 34 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 Keithley Instruments, Inc.

4 FDA decisions under this applicant name. See the company

  • K942083Advanced Therapy DosimeterKeithley Instruments, Inc. · 1994
  • K932598TN-RD-50Keithley Instruments, Inc. · 1994
  • K854110Keithley Model 75100 & 75200Keithley Instruments, Inc. · 1986

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/K874893 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874893: Model 35300 Tracker (TM) Therapy Beam Evaluator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874893

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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