510(k) Report

510(k) · Cleared

Cleared

Ceramic Blade Electrode

K960255510(k) TraditionalCleared Mar 27, 199670-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

Utah Medical Products, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 27, 1996 as substantially equivalent to K905263 (Utah Medical Products, Inc., 1991) and 2 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1978. 45 later devices descend from it.

Decided
Mar 27, 1996
Review
70 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K780977 (1978). 3 ancestors in all. 45 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1991: 2 other ancestors2024: 3 descendants cleared2008: 3 descendants cleared2015: 4 descendants cleared2009: 2 descendants cleared2018: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2012: 2 descendants cleared2014: 4 descendants cleared2010: 3 descendants cleared2016: 6 descendants cleared2011: 1 descendant cleared2020: 3 descendants cleared2025: 2 descendants cleared2017: 2 descendants cleared2013: 1 descendant cleared2019: 1 descendant cleared2022: 4 descendants cleared2026: 1 descendant clearedK780977 · Single Use Blade Electrode · Aspen Laboratories, Inc. · 197819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 16 descendants4 generations forward: 7 descendants5 generations forward: 9 descendants6 generations forward: 2 descendants K780977 · Single Use Blade Electrode · Aspen Laboratories, Inc. · 19780+5
  1. Root · 1 generation backK780977 Single Use Blade ElectrodeAspen Laboratories, Inc. · 1978
  2. This deviceK960255 Ceramic Blade ElectrodeUtah Medical Products, Inc. · 1996
  3. Descendant · cites it directly · 33 of its ownK073057 Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue…Peak Surgical, Inc. · 2008
  4. Descendant · 2 generations on · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
  5. Descendant · 3 generations on · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
  6. Descendant · 2 generations on · 8 of its ownK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
  7. Descendant · cites it directly · 8 of its ownK081791 E-Z Clean Electrosurgical ElectrodeMegadyne Medical Products, Inc. · 2008 · Recalled

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2008: 32009: 22010: 32011: 12012: 22013: 12014: 42015: 42016: 62017: 22018: 12019: 12020: 32021: 12022: 42023: 12024: 32025: 22026: 1
2008high 6 (2016) · low 1 (2011)2026

Most influential descendants

Showing 5 of 45 · See all
  • K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc. · 2008 · cites it directly33descendants
  • K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · 2 generations on24descendants
  • K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · 3 generations on8descendants
  • K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009 · 2 generations on8descendants
  • K081791E-Z Clean Electrosurgical ElectrodeMegadyne Medical Products, Inc. · 2008 · cites it directly8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K780977Single Use Blade ElectrodeAspen Laboratories, Inc.1978—
0 (this device)K960255Ceramic Blade ElectrodeUtah Medical Products, Inc.1996—
+1K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection…Peak Surgical, Inc.2008—
+2K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection…Peak Surgical, Inc.20081
+3K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.2010—
+2K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.2009—
+1K081791E-Z Clean Electrosurgical ElectrodeMegadyne Medical Products, Inc.20081

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200830
200920
201030
201110
201220
201310
201440
201540
201660
201720
201810
201910
202030
202110
202240
202310
202430
202520
202610
FIG. 1 — Lineage of K960255, 1978–2026Source: 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), the FDA summary (predicates and indications), 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
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K905263Utah Essu
Summary page 1
…ith the CBE-1XX blades, cauterization of the wound will occur while the cut is being made. The CBE device is substantially equivalent to the UMP DLP-L11 Loop Electrode (K905263), the Mega Dyne E-Z Clean Blade (K913473), and the Aspen Labs Blade Electrode #60-0180-001 (K780977). The posterior end of the CB…
Utah Medical Products, Inc.1991—
*K913473E-Z Clean Electrode
Summary page 1
…the wound will occur while the cut is being made. The CBE device is substantially equivalent to the UMP DLP-L11 Loop Electrode (K905263), the Mega Dyne E-Z Clean Blade (K913473), and the Aspen Labs Blade Electrode #60-0180-001 (K780977). The posterior end of the CBE device fits snugly into a standard elec…
Megadyne Medical Products, Inc.1991—
*K780977Single Use Blade Electrode
Summary page 1
…device is substantially equivalent to the UMP DLP-L11 Loop Electrode (K905263), the Mega Dyne E-Z Clean Blade (K913473), and the Aspen Labs Blade Electrode #60-0180-001 (K780977). The posterior end of the CBE device fits snugly into a standard electrosurgical pen which is connected to an FDA-approved elect…
Aspen Laboratories, Inc.1978—

What descends from it? (45)

See all 45

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

NumberDeviceApplicantDecidedDescendants
K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model…Peak Surgical, Inc.200833
K081791E-Z Clean Electrosurgical ElectrodeMegadyne Medical Products, Inc.20088
K233002Beed 2,5, Beed 3,8Excelsior Resources, LLC20240
K150824TD-WandTdm Surgitech, Inc.20150

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K073057 (Peak Surgical, Inc., 2008) has gone furthest, with 33 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—

What is it indicated for?

The Utah Medical Products, Inc. (UMP) Ceramic Blade Electrodes (CBE) are intended for use in virtually every surgical discipline where flat, paddle-type electrosurgical blades are used for making straight cuts through tissue. The CBE-2XX blades are intended for use in procedures that require precise cuts where only light or no hemostasis is desired. The CBE-1XX blades are intended for use in procedures where a greater level of hemostasis is desired. When an electrosurgical generator blend mode is used for cutting with the CBE-1XX blades, cauterization of the wound will occur while the cut is being made.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Utah Medical Products, Inc.

38 FDA decisions under this applicant name. See the company

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  • K123310Finesse 3RD Generation (Models Finesse+ and Finesseii+)Utah Medical Products, Inc. · 2013
  • K101535BT-CathUtah Medical Products, Inc. · 2011
  • K063611Saline/ Contrast Media Infusion CatheterUtah Medical Products, Inc. · 2007
  • K001874Peripherally Inserted Central CatheterUtah Medical Products, Inc. · 2000

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https://510kreport.com/device/K960255 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960255: Ceramic Blade Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960255

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026