510(k) Report

510(k) · Cleared

Cleared

Balloon Electrosurgical Probes and Devices

K943014510(k) TraditionalCleared Mar 11, 1996626-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

Ximed Medical Systems · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Mar 11, 1996 after a 626-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 44 later devices descend from it.

Decided
Mar 11, 1996
Review
626 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2001: 1 descendant cleared2003: 3 descendants cleared2004: 3 descendants cleared2005: 1 descendant cleared2010: 3 descendants cleared2006: 5 descendants cleared2008: 2 descendants cleared2012: 2 descendants cleared2014: 2 descendants cleared2019: 2 descendants cleared2013: 1 descendant cleared2009: 3 descendants cleared2007: 1 descendant cleared2015: 1 descendant cleared2017: 2 descendants cleared2018: 2 descendants cleared2016: 2 descendants cleared2024: 2 descendants cleared2021: 3 descendants cleared2025: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK943014 Balloon Electrosurgical Probes and DevicesXimed Medical Systems · 1996
  2. Descendant · cites it directly · 42 of its ownK023765 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002
  3. Descendant · cites it directly · 42 of its ownK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
  4. Descendant · 2 generations on · 41 of its ownK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
  5. Descendant · 2 generations on · 39 of its ownK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
  6. Descendant · 2 generations on · 38 of its ownK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 32004: 32005: 12006: 52007: 12008: 22009: 32010: 32012: 22013: 12014: 22015: 12016: 22017: 22018: 22019: 22020: 12021: 32024: 22025: 1
2001high 5 (2006) · low 0 (2011)2026

Most influential descendants

Showing 5 of 44 · See all
  • K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002 · cites it directly42descendants
  • K013139Stellartech Coagulation SystemStellartech Research Corp. · 2001 · cites it directly42descendants
  • K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003 · 2 generations on41descendants
  • K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp. · 2003 · 2 generations on39descendants
  • K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2003 · 2 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943014Balloon Electrosurgical Probes and DevicesXimed Medical Systems1996—
+1K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2002—
+1K013139Stellartech Coagulation SystemStellartech Research Corp.2001—
+2K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.2003—
+2K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.2003—
+2K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200330
200430
200510
200650
200710
200820
200930
201030
201220
201310
201420
201510
201620
201720
201820
201920
202010
202130
202420
202510
FIG. 1 — Lineage of K943014, 1996–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (44)

See all 44

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

NumberDeviceApplicantDecidedDescendants
K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242
K013139Stellartech Coagulation SystemStellartech Research Corp.200142

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, K023765 (Stellartech Research Corp., 2002) has gone furthest, with 42 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 Ximed Medical Systems

11 FDA decisions under this applicant name. See the company

  • K946377Electroprobe Single Use Electrosurgical ProbesXimed Medical Systems · 1995
  • K933757Hand-Held Irrigation PumpXimed Medical Systems · 1994
  • K933458Surgical TrocarsXimed Medical Systems · 1994
  • K922714Universal Irrigation & Suction Tubing SetXimed Medical Systems · 1993
  • K922523Bipolar Electrosurgical Probes & InstrumentsXimed Medical Systems · 1992

Recent decisions in GEI

The GEI category page

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K943014 · printed Nov 4, 2026

Cite this page

510(k) Report. “K943014: Balloon Electrosurgical Probes and Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943014

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026