510(k) Report

510(k) · Cleared

Cleared

Excalibur Plus Electrosurgical Unit

K953007510(k) TraditionalCleared Aug 21, 199554-day reviewClass II21 CFR 878.4400

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

Aspen Laboratories, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 21, 1995 after a 54-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 38 later devices descend from it.

Decided
Aug 21, 1995
Review
54 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2010: 4 descendants cleared1998: 1 descendant cleared2020: 4 descendants cleared2008: 2 descendants cleared2009: 1 descendant cleared2018: 1 descendant cleared2026: 2 descendants cleared2012: 2 descendants cleared2014: 4 descendants cleared2016: 4 descendants cleared2015: 3 descendants cleared2011: 1 descendant cleared2017: 1 descendant cleared2013: 1 descendant cleared2019: 1 descendant cleared2024: 1 descendant cleared2022: 4 descendants cleared2025: 1 descendant cleared1995200020052010201520202025
  1. This deviceK953007 Excalibur Plus Electrosurgical UnitAspen Laboratories, Inc. · 1995
  2. Descendant · cites it directly · 34 of its ownK981724 O.R.Pro 300 Electrosurgical Generator Model 40001-100Medtrex, Inc. · 1998
  3. Descendant · 2 generations on · 33 of its ownK073057 Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue…Peak Surgical, Inc. · 2008
  4. Descendant · 3 generations on · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
  5. Descendant · 4 generations on · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
  6. Descendant · 3 generations on · 8 of its ownK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

1998: 12008: 22009: 12010: 42011: 12012: 22013: 12014: 42015: 32016: 42017: 12018: 12019: 12020: 42022: 42024: 12025: 12026: 2
1998high 4 (2010) · low 0 (1999)2026

Most influential descendants

Showing 5 of 38 · See all
  • K981724O.R.Pro 300 Electrosurgical Generator Model 40001-100Medtrex, Inc. · 1998 · cites it directly34descendants
  • K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc. · 2008 · 2 generations on33descendants
  • K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · 3 generations on24descendants
  • K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · 4 generations on8descendants
  • K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953007Excalibur Plus Electrosurgical UnitAspen Laboratories, Inc.1995—
+1K981724O.R.Pro 300 Electrosurgical Generator Model 40001-100Medtrex, Inc.1998—
+2K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection…Peak Surgical, Inc.2008—
+3K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection…Peak Surgical, Inc.20081
+4K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.2010—
+3K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200820
200910
201040
201110
201220
201310
201440
201530
201640
201710
201810
201910
202040
202240
202410
202510
202620
FIG. 1 — Lineage of K953007, 1995–2026Source: 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 GEI? 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 GEI device

  1. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (38)

See all 38

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

NumberDeviceApplicantDecidedDescendants
K981724O.R.Pro 300 Electrosurgical Generator Model 40001-100Medtrex, Inc.199834
K102114Medrange Electrosurgical GeneratorMedrange Corporation20102

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, K981724 (Medtrex, Inc., 1998) has gone furthest, with 34 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

More from Aspen Laboratories, Inc.

55 FDA decisions under this applicant name. See the company

  • K981220System 7500 Abc Electrosurgical UnitAspen Laboratories, Inc. · 1998
  • K963088Sheath, Electrosurgical PencilAspen Laboratories, Inc. · 19965 recalls
  • K955834System 6500 Abc Electrosurgical UnitAspen Laboratories, Inc. · 1996
  • K9602964000 ETMAspen Laboratories, Inc. · 1996
  • K953081Beamer PlusAspen Laboratories, Inc. · 1995

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https://510kreport.com/device/K953007 · printed Nov 5, 2026

Cite this page

510(k) Report. “K953007: Excalibur Plus Electrosurgical Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953007

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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