510(k) Report

510(k) · Cleared

Cleared

Simulix-HP

K946128510(k) TraditionalCleared May 12, 1995148-day reviewClass II21 CFR 892.5840

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

Oldelft Corp. of America · KPQ System, Simulation, Radiation Therapy

Cleared on May 12, 1995 after a 148-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
May 12, 1995
Review
148 days
Class
Class II
Product code
KPQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2010: 1 descendant cleared2004: 1 descendant cleared2005: 1 descendant cleared2009: 1 descendant cleared1995200020052010201520202025
  1. This deviceK946128 Simulix-HPOldelft Corp. of America · 1995
  2. Descendant · cites it directly · 2 of its ownK033470 Simulix EvolutionNucletron Corporation · 2004
  3. Descendant · cites it directly · 0 of its ownK101038 Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerAcceletronics Digital Imaging, LLC · 2010
  4. Descendant · 2 generations on · 0 of its ownK090706 Oncentra Simulation 2.3Nucletron Corporation · 2009
  5. Descendant · 2 generations on · 0 of its ownK052361 Simulix-Evolution with Oncentra ConebeamNucletron Corporation · 2005

Most influential descendants

Showing 4 of 4 · See all
  • K033470Simulix EvolutionNucletron Corporation · 2004 · cites it directly2descendants
  • K101038Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerAcceletronics Digital Imaging, LLC · 2010 · cites it directly0descendants
  • K090706Oncentra Simulation 2.3Nucletron Corporation · 2009 · 2 generations on0descendants
  • K052361Simulix-Evolution with Oncentra ConebeamNucletron Corporation · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K946128Simulix-HPOldelft Corp. of America1995—
+1K033470Simulix EvolutionNucletron Corporation2004—
+1K101038Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerAcceletronics Digital Imaging, LLC2010—
+2K090706Oncentra Simulation 2.3Nucletron Corporation2009—
+2K052361Simulix-Evolution with Oncentra ConebeamNucletron Corporation2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200910
201010
FIG. 1 — Lineage of K946128, 1995–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 KPQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K033470Simulix EvolutionNucletron Corporation20042
K101038Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerAcceletronics Digital Imaging, LLC20100

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, K033470 (Nucletron Corporation, 2004) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KPQ devices

KPQ System, Simulation, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPQ

1in 2014

2007: 12008: 12009: 12010: 12013: 12014: 1
2007high 1 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPQ

Too few KPQ 510(k)s in any year since 2007 to give a median.

Recalls per year · KPQ

1in 2014

2007: 62008: 32009: 12012: 12013: 12014: 1
2007high 6 (2007) · low 0 (2010)2026

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

Adverse event reports per year · KPQ

1in 2020

2007: 172008: 122009: 72010: 102011: 122012: 112013: 12014: 32019: 12020: 1
2007high 17 (2007) · low 0 (2015)2025

MAUDE reports naming product code KPQ, 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
20071—617
20081—312
20091—17
20101—010
20110—012
20120—111
20131—11
20141—13
20150—00
20160—00
20170—00
20180—00
20190—01
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Oldelft Corp. of America

9 FDA decisions under this applicant name. See the company

  • K980296Oldelft DigidelcaOldelft Corp. of America · 1998
  • K973219Amber DUOldelft Corp. of America · 1997
  • K950037N 800 HFOldelft Corp. of America · 1995
  • K932848Simulix-MC CT ExtensionOldelft Corp. of America · 1994
  • K923584Therapax DXT 300 Series 3Oldelft Corp. of America · 1993

Recent decisions in KPQ

The KPQ category page

  • K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
  • K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
  • K101038Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerAcceletronics Digital Imaging, LLC · 2010
  • K090706Oncentra Simulation 2.3Nucletron Corporation · 2009
  • K083591Ikoengelo, Version 2Ikoetech, LLC · 2008

https://510kreport.com/device/K946128 · printed Nov 6, 2026

Cite this page

510(k) Report. “K946128: Simulix-HP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946128

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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