510(k) Report

510(k) · Cleared

Cleared

Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable Connector Cable

K000720510(k) TraditionalCleared May 30, 200088-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

Somnus Medical Technologies, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 30, 2000 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 78 later devices descend from it.

Decided
May 30, 2000
Review
88 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 2 descendants cleared2004: 3 descendants cleared2008: 7 descendants cleared2022: 3 descendants cleared2012: 8 descendants cleared2013: 8 descendants cleared2016: 7 descendants cleared2005: 2 descendants cleared2009: 1 descendant cleared2014: 4 descendants cleared2011: 6 descendants cleared2015: 6 descendants cleared2010: 3 descendants cleared2018: 2 descendants cleared2021: 2 descendants cleared2017: 4 descendants cleared2019: 1 descendant cleared2020: 3 descendants cleared2023: 5 descendants cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK000720 Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable…Somnus Medical Technologies, Inc. · 2000
  2. Descendant · cites it directly · 77 of its ownK020778 Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420Gyrus Ent LLC · 2002
  3. Descendant · 2 generations on · 76 of its ownK021777 Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty…Gyrus Ent LLC · 2002
  4. Descendant · 3 generations on · 50 of its ownK034004 Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004
  5. Descendant · 4 generations on · 44 of its ownK072302 Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008
  6. Descendant · 5 generations on · 42 of its ownK081542 Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008

Showing 5 of 78 descendants. See all descendants

Descendants cleared per year

2002: 22004: 32005: 22008: 72009: 12010: 32011: 62012: 82013: 82014: 42015: 62016: 72017: 42018: 22019: 12020: 32021: 22022: 32023: 52026: 1
2002high 8 (2012) · low 0 (2003)2026

Most influential descendants

Showing 5 of 78 · See all
  • K020778Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420Gyrus Ent LLC · 2002 · cites it directly77descendants
  • K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC · 2002 · 2 generations on76descendants
  • K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC · 2004 · 3 generations on50descendants
  • K072302Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 4 generations on44descendants
  • K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc. · 2008 · 5 generations on42descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000720Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable Connector…Somnus Medical Technologies, Inc.2000—
+1K020778Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420Gyrus Ent LLC2002—
+2K021777Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and…Gyrus Ent LLC2002—
+3K034004Diego RF Powered Dissector and Drill System ConsoleGyrus Ent LLC2004—
+4K072302Entellus Medical RS-Series SystemEntellus Medical, Inc.2008—
+5K081542Modification to Entellus Medical RS-Series SystemEntellus Medical, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200430
200520
200870
200910
201030
201160
201280
201380
201440
201560
201670
201740
201820
201910
202030
202120
202230
202350
202610
FIG. 1 — Lineage of K000720, 2000–2026Source: 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (78)

See all 78

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

NumberDeviceApplicantDecidedDescendants
K020778Gyrus Ent Somnoplasty Tissue Coagulating Electrode, Model 2420Gyrus Ent LLC200277

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, K020778 (Gyrus Ent LLC, 2002) has gone furthest, with 77 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 Somnus Medical Technologies, Inc.

16 FDA decisions under this applicant name. See the company

  • K001438Somnus Model S2 Electrosurgical GeneratorSomnus Medical Technologies, Inc. · 2000
  • K000501Electrosurgical Generator, Model S1Somnus Medical Technologies, Inc. · 2000
  • K982717Somnoplasty System, Models S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200Somnus Medical Technologies, Inc. · 1998
  • K973701Somnus Tissue Coagulating ElectrodeSomnus Medical Technologies, Inc. · 1998
  • K970837Somnus Model 6000 Disposable Tissue Coagulating ElectrodeSomnus Medical Technologies, Inc. · 1998

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https://510kreport.com/device/K000720 · printed Nov 3, 2026

Cite this page

510(k) Report. “K000720: Somnus Disposable Tissue Coagulating Electrode and Somnus Reusable Connector Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K000720

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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