510(k) Report

510(k) · Cleared

Cleared

Sim/Plant

K924810510(k) TraditionalCleared Jan 15, 1993112-day reviewClass II21 CFR 892.1750

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

Columbia Scientific, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Jan 15, 1993 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 381 later devices descend from it.

Decided
Jan 15, 1993
Review
112 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 3 descendants cleared2007: 4 descendants cleared2011: 9 descendants cleared2006: 6 descendants cleared2014: 13 descendants cleared2005: 3 descendants cleared2008: 3 descendants cleared2009: 3 descendants cleared2012: 12 descendants cleared2016: 17 descendants cleared2013: 16 descendants cleared2018: 20 descendants cleared2022: 26 descendants cleared2010: 2 descendants cleared2017: 22 descendants cleared2019: 23 descendants cleared2015: 12 descendants cleared2020: 29 descendants cleared2024: 25 descendants cleared2023: 43 descendants cleared2021: 24 descendants cleared2025: 33 descendants cleared2026: 33 descendants cleared1990200020102020
  1. This deviceK924810 Sim/PlantColumbia Scientific, Inc. · 1993
  2. Descendant · cites it directly · 379 of its ownK033849 Simplant SystemMaterialise NV · 2004
  3. Descendant · 2 generations on · 143 of its ownK073449 SurgicaseMaterialise NV · 2008
  4. Descendant · 2 generations on · 141 of its ownK073468 MimicsMaterialise NV · 2008
  5. Descendant · 3 generations on · 99 of its ownK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
  6. Descendant · 3 generations on · 71 of its ownK111863 Signature Planner,Signature GuidesMaterialise NV · 2012

Showing 5 of 381 descendants. See all descendants

Descendants cleared per year

2004: 32005: 32006: 62007: 42008: 32009: 32010: 22011: 92012: 122013: 162014: 132015: 122016: 172017: 222018: 202019: 232020: 292021: 242022: 262023: 432024: 252025: 332026: 33
2004high 43 (2023) · low 2 (2010)2026

Most influential descendants

Showing 5 of 381 · See all
  • K033849Simplant SystemMaterialise NV · 2004 · cites it directly379descendants
  • K073449SurgicaseMaterialise NV · 2008 · 2 generations on143descendants
  • K073468MimicsMaterialise NV · 2008 · 2 generations on141descendants
  • K102795Signature Planner; Signature GuidesMaterialise NV · 2011 · 3 generations on99descendants
  • K111863Signature Planner,Signature GuidesMaterialise NV · 2012 · 3 generations on71descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924810Sim/PlantColumbia Scientific, Inc.1993—
+1K033849Simplant SystemMaterialise NV2004—
+2K073449SurgicaseMaterialise NV2008—
+2K073468MimicsMaterialise NV2008—
+3K102795Signature Planner; Signature GuidesMaterialise NV20114
+3K111863Signature Planner,Signature GuidesMaterialise NV2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200430
200530
200660
200740
200830
200930
201020
201190
2012120
2013160
2014130
2015120
2016170
2017220
2018200
2019230
2020290
2021240
2022260
2023430
2024250
2025330
2026330
FIG. 1 — Lineage of K924810, 1993–2026Source: 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 JAK? 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 JAK device

  1. #1 K230223 iCAC Devicescore 23.5 · 12 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? (381)

See all 381

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

NumberDeviceApplicantDecidedDescendants
K033849Simplant SystemMaterialise NV2004379
K040224CadimplantPraxim, Inc.20040

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, K033849 (Materialise NV, 2004) has gone furthest, with 379 descendants of its own.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

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

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, 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
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

More from Columbia Scientific, Inc.

7 FDA decisions under this applicant name. See the company

  • K011180CT/Master, Version 1.0Columbia Scientific, Inc. · 2001
  • K897000Imagemaster-101(TM)Columbia Scientific, Inc. · 1990
  • K8853223D/DentalColumbia Scientific, Inc. · 1989
  • K880404Csi/QCTColumbia Scientific, Inc. · 1988
  • K870513CSI/3DColumbia Scientific, Inc. · 1987

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https://510kreport.com/device/K924810 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924810: Sim/Plant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924810

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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