510(k) Report

510(k) · Cleared

Cleared

IPU RX-2

K964327510(k) TraditionalCleared Jan 17, 199779-day reviewClass II21 CFR 892.2050

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

Medirex, Inc. · LLZ System, Image Processing, Radiological

Cleared on Jan 17, 1997 after a 79-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.

Decided
Jan 17, 1997
Review
79 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 2 descendants cleared2006: 3 descendants cleared2005: 1 descendant cleared2012: 1 descendant cleared2008: 1 descendant cleared2026: 2 descendants cleared1995200020052010201520202025
  1. This deviceK964327 IPU RX-2Medirex, Inc. · 1997
  2. Descendant · cites it directly · 9 of its ownK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
  3. Descendant · 2 generations on · 8 of its ownK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
  4. Descendant · 3 generations on · 6 of its ownK053640 IntegraDirex Systems Corp. · 2006
  5. Descendant · 3 generations on · 3 of its ownK062147 Integra SLDirex Systems Corp. · 2006
  6. Descendant · 4 generations on · 2 of its ownK072538 Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2004: 22005: 12006: 32008: 12012: 12026: 2
2004high 3 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all
  • K040470Tripter X-1 CompactDirex Systems Corp. · 2004 · cites it directly9descendants
  • K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004 · 2 generations on8descendants
  • K053640IntegraDirex Systems Corp. · 2006 · 3 generations on6descendants
  • K062147Integra SLDirex Systems Corp. · 2006 · 3 generations on3descendants
  • K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964327IPU RX-2Medirex, Inc.1997—
+1K040470Tripter X-1 CompactDirex Systems Corp.2004—
+2K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp.2004—
+3K053640IntegraDirex Systems Corp.2006—
+3K062147Integra SLDirex Systems Corp.2006—
+4K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200510
200630
200810
201210
202620
FIG. 1 — Lineage of K964327, 1997–2026Source: 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 LLZ? 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 LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (10)

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

NumberDeviceApplicantDecidedDescendants
K040470Tripter X-1 CompactDirex Systems Corp.20049

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, K040470 (Direx Systems Corp., 2004) has gone furthest, with 9 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

More from Medirex, Inc.

7 FDA decisions under this applicant name. See the company

  • P920034/S003Tripter-X1Medirex, Inc. · 1998
  • P920034/S002Tripter-X1 Series Shockwave LithotriptersMedirex, Inc. · 1998
  • P920034/S001Tripter-X1 Series Shockwave LithotriptersMedirex, Inc. · 1997
  • K965013Digiscope RX-2 (9 Option)Medirex, Inc. · 1997
  • P920034Tripter-X1 NovaMedirex, Inc. · 1996

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K964327 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964327: IPU RX-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964327

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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