510(k) Report

510(k) · Cleared

Cleared

Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model PS200-040

K073057510(k) TraditionalCleared Jul 22, 2008266-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

Peak Surgical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jul 22, 2008 as substantially equivalent to K981724 (Medtrex, Inc., 1998) and 4 other predicates after a 266-day review. Its family tree reaches back 2 generations to 1978. 33 later devices descend from it.

Decided
Jul 22, 2008
Review
266 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K780977 (1978). 12 ancestors in all. 33 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor1979: 1 other ancestor2000: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor1991: 2 other ancestors2008: 1 descendant cleared2009: 1 descendant cleared2018: 1 descendant cleared2012: 2 descendants cleared2014: 4 descendants cleared2010: 3 descendants cleared2016: 4 descendants cleared2015: 3 descendants cleared2011: 1 descendant cleared2020: 3 descendants cleared2017: 1 descendant cleared2013: 1 descendant cleared2019: 1 descendant cleared2024: 1 descendant cleared2022: 4 descendants cleared2026: 1 descendant cleared2025: 1 descendant clearedK780977 · Single Use Blade Electrode · Aspen Laboratories, Inc. · 1978K960255 · Ceramic Blade Electrode · Utah Medical Products, Inc. · 199619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 6 other ancestors 1 generation forward: 3 descendants2 generations forward: 13 descendants3 generations forward: 6 descendants4 generations forward: 9 descendants5 generations forward: 2 descendants K960255 · Ceramic Blade Electrode · Utah Medical Products, Inc. · 1996K780977 · Single Use Blade Electrode · Aspen Laboratories, Inc. · 19780+5
  1. Root · 2 generations backK780977 Single Use Blade ElectrodeAspen Laboratories, Inc. · 1978
  2. 1 generation backK960255 Ceramic Blade ElectrodeUtah Medical Products, Inc. · 1996
  3. This deviceK073057 Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue…Peak Surgical, Inc. · 2008
  4. Descendant · cites it directly · 24 of its ownK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
  5. Descendant · 2 generations on · 8 of its ownK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
  6. Descendant · cites it directly · 8 of its ownK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
  7. Descendant · 2 generations on · 7 of its ownK142410 Elliquence ElectrodesElliquence, LLC · 2015
  8. Descendant · 2 generations on · 6 of its ownK160041 Cobbra RF Tissue DissectorElliquence, LLC · 2016

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 32011: 12012: 22013: 12014: 42015: 32016: 42017: 12018: 12019: 12020: 32022: 42024: 12025: 12026: 1
2008high 4 (2014) · low 0 (2021)2026

Most influential descendants

Showing 5 of 33 · See all
  • K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc. · 2008 · cites it directly24descendants
  • K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010 · 2 generations on8descendants
  • K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009 · cites it directly8descendants
  • K142410Elliquence ElectrodesElliquence, LLC · 2015 · 2 generations on7descendants
  • K160041Cobbra RF Tissue DissectorElliquence, LLC · 2016 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K780977Single Use Blade ElectrodeAspen Laboratories, Inc.1978—
−1K960255Ceramic Blade ElectrodeUtah Medical Products, Inc.1996—
0 (this device)K073057Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection…Peak Surgical, Inc.2008—
+1K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection…Peak Surgical, Inc.20081
+2K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc.2010—
+1K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.2009—
+2K142410Elliquence ElectrodesElliquence, LLC2015—
+2K160041Cobbra RF Tissue DissectorElliquence, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199120
199410
199520
199610
199810
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201030
201110
201220
201310
201440
201530
201640
201710
201810
201910
202030
202240
202410
202510
202610
FIG. 1 — Lineage of K073057, 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
Get a 510(k) Report

What was it cleared against? (5)

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
*K981724O.R.Pro 300 Electrosurgical Generator Model 40001-100
Summary page 1
…ion Device and Accessories (21 CFR 878.4400) 3. Predicate Devices: Medtrex OR Pro 300 Electrosurgical Generator (K98 1724) Eliman Surgitron 120 IEC (K013255) Valleylab E25 15 Electrosurgical Accessory (K79 1639) Val…
Medtrex, Inc.1998—
*K013255Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF
Summary page 1
…Accessories (21 CFR 878.4400) 3. Predicate Devices: Medtrex OR Pro 300 Electrosurgical Generator (K98 1724) Eliman Surgitron 120 IEC (K013255) Valleylab E25 15 Electrosurgical Accessory (K79 1639) Valleylab Coated Electrode (K962044) U…
Ellman Intl., Inc.2001—
*K791639Model E2515 Electrosurgical Accessory
Summary page 1
…Medtrex OR Pro 300 Electrosurgical Generator (K98 1724) Eliman Surgitron 120 IEC (K013255) Valleylab E25 15 Electrosurgical Accessory (K79 1639) Valleylab Coated Electrode (K962044) Utah Medical Ceramic Blade Electrode (K960255) 4. Device…
Valleylab, Inc.1979—
*K962044Valleylab Coated Electrodes
Summary page 1
…rator (K98 1724) Eliman Surgitron 120 IEC (K013255) Valleylab E25 15 Electrosurgical Accessory (K79 1639) Valleylab Coated Electrode (K962044) Utah Medical Ceramic Blade Electrode (K960255) 4. Device description: The PULSAR Generator is…
Valleylab, Inc.1996—
*K960255Ceramic Blade Electrode
Summary page 1
…255) Valleylab E25 15 Electrosurgical Accessory (K79 1639) Valleylab Coated Electrode (K962044) Utah Medical Ceramic Blade Electrode (K960255) 4. Device description: The PULSAR Generator is a microcontroller based, isolated output, elec…
Utah Medical Products, Inc.1996—

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K082786Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection DevicesPeak Surgical, Inc.200824
K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc.20098
K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy20183

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?

  • The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 17.8 years on median.
  • None of the 12 ancestors has a recall.
  • Of its descendants, K082786 (Peak Surgical, Inc., 2008) has gone furthest, with 24 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. 2008, this device’s year, is highlighted.

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 PULSAR Generator with the PEAK PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.

Indications for use as stated in the FDA summary.

More from Peak Surgical, Inc.

7 FDA decisions under this applicant name. See the company

  • K103775Peak Suction CoagulatorPeak Surgical, Inc. · 2011
  • K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc. · 2010
  • K102029Peak Pulsar II Generator Model PS100-102Peak Surgical, Inc. · 2010
  • K093695Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
  • K083415Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009

Recent decisions in GEI

The GEI category page

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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
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https://510kreport.com/device/K073057 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073057: Pulsar Generator, Model PS100-100, and Peak Plasmablade Tissue Dissection Device, Model PS200-040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073057

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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