510(k) Report

510(k) · Cleared

Cleared

STP Complete Module Set

K892425510(k) TraditionalCleared Mar 23, 1990347-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

Leibinger & Fischer, Ltd. · IYE Accelerator, Linear, Medical

Cleared on Mar 23, 1990 after a 347-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.

Decided
Mar 23, 1990
Review
347 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
0

25 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared1999: 3 descendants cleared1995: 1 descendant cleared1998: 2 descendants cleared2012: 1 descendant cleared1997: 1 descendant cleared2001: 1 descendant cleared2010: 2 descendants cleared2005: 1 descendant cleared2016: 2 descendants cleared2023: 3 descendants cleared2014: 1 descendant cleared2013: 1 descendant cleared2024: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK892425 STP Complete Module SetLeibinger & Fischer, Ltd. · 1990
  2. Descendant · cites it directly · 17 of its ownK961120 Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc. · 1996
  3. Descendant · cites it directly · 8 of its ownK982463 Extracranial Radiotherapy SystemHowmedica, Inc. · 1998
  4. Descendant · 2 generations on · 7 of its ownK991336 Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999
  5. Descendant · cites it directly · 7 of its ownK972324 Leksell Stereotactic SystemElekta Instrument AB · 1998 · Recalled
  6. Descendant · 3 generations on · 6 of its ownK100691 Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

1995: 11996: 21997: 11998: 21999: 32001: 12005: 12010: 22012: 12013: 12014: 12016: 22017: 12018: 12021: 12023: 32024: 1
1995high 3 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 25 · See all
  • K961120Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc. · 1996 · cites it directly17descendants
  • K982463Extracranial Radiotherapy SystemHowmedica, Inc. · 1998 · cites it directly8descendants
  • K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999 · 2 generations on7descendants
  • K972324Leksell Stereotactic SystemElekta Instrument AB · 1998 · cites it directly7descendants
  • K100691Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K892425STP Complete Module SetLeibinger & Fischer, Ltd.1990—
+1K961120Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc.1996—
+1K982463Extracranial Radiotherapy SystemHowmedica, Inc.1998—
+2K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco)1999—
+1K972324Leksell Stereotactic SystemElekta Instrument AB19981
+3K100691Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199510
199620
199710
199820
199930
200110
200510
201020
201210
201310
201410
201620
201710
201810
202110
202330
202410
FIG. 1 — Lineage of K892425, 1990–2024Source: 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? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K961120Marker System for Stereotaxic NavigationHowmedica Leibinger, Inc.199617
K982463Extracranial Radiotherapy SystemHowmedica, Inc.19988
K972324Leksell Stereotactic SystemElekta Instrument AB19987
K946033Leibinger Stereoplan Plus Sterotactic Treatment Plan Ing Software PackageLeibinger GmbH19951
K991706Virtuoso-Stereotaxic Planning SoftwareStryker Corp.19990
K961484Cass System (Modification)Medical Instrumentation & Diagnostics Corp.(Midco)19960

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, K961120 (Howmedica Leibinger, Inc., 1996) has gone furthest, with 17 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 Leibinger & Fischer, Ltd.

2 FDA decisions under this applicant name. See the company

  • K896450Neuro N 50 Lesion GeneratorLeibinger & Fischer, Ltd. · 1991

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/K892425 · printed Nov 3, 2026

Cite this page

510(k) Report. “K892425: STP Complete Module Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K892425

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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