510(k) Report

510(k) · Cleared

Cleared

KLS Martin Electrosurgical Instruments

K082505510(k) TraditionalCleared Jun 12, 2009287-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

Kl Martin L.P. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jun 12, 2009 as substantially equivalent to K051429 (Guenter Bissinger Medizintechnik GmbH, 2005) and 4 other predicates after a 287-day review. Its family tree reaches back 4 generations to 1992.

Decided
Jun 12, 2009
Review
287 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K923332 (1992). 17 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 2 other ancestors1998: 4 other ancestors1997: 3 other ancestors1996: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestorK923332 · Electrosurgical Electrodes · Premier Dental Products Co. · 1992K970987 · Electrosurgical Electrode · Fusion Medical Technologies, Inc. · 1997K992931 · Non-Stick Bipolar Forceps · Silverglide Surgical Technologies · 1999K051429 · Claris Non-Stick Bipolar Forceps · Guenter Bissinger Medizintechnik GmbH · 200519901995200020052010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors3 generations back: 6 other ancestors4 generations back: 1 other ancestor K051429 · Claris Non-Stick Bipolar Forceps · Guenter Bissinger Medizintechnik GmbH · 2005K992931 · Non-Stick Bipolar Forceps · Silverglide Surgical Technologies · 1999K970987 · Electrosurgical Electrode · Fusion Medical Technologies, Inc. · 1997K923332 · Electrosurgical Electrodes · Premier Dental Products Co. · 19920
  1. Root · 4 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
  2. 3 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
  3. 2 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
  4. 1 generation backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
  5. This deviceK082505 KLS Martin Electrosurgical InstrumentsKl Martin L.P. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K923332Electrosurgical ElectrodesPremier Dental Products Co.1992—
−3K970987Electrosurgical ElectrodeFusion Medical Technologies, Inc.1997—
−2K992931Non-Stick Bipolar ForcepsSilverglide Surgical Technologies1999—
−1K051429Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH2005—
0 (this device)K082505KLS Martin Electrosurgical InstrumentsKl Martin L.P.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
199610
199730
199840
200420
FIG. 1 — Lineage of K082505, 1992–2009Source: 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
*K051429Claris Non-Stick Bipolar Forceps
Summary page 1
…al, Cutting & Coagulation & Accessories (CFR 878.4400) Regulatory Class: II Predicate Devices: Clads Non-Stick Bipolar Forceps (K051429) BiTech Bipolar Scissors (K042077) POWERGRIP Bipolar Coagulation Forcep…
Guenter Bissinger Medizintechnik GmbH2005—
*K042077Bitech Bipolar Scissors
Summary page 1
…ories (CFR 878.4400) Regulatory Class: II Predicate Devices: Clads Non-Stick Bipolar Forceps (K051429) BiTech Bipolar Scissors (K042077) POWERGRIP Bipolar Coagulation Forceps (K033177)…
Guenter Bissinger Medizintechnik GmbH2004—
*K033177Powergrip Bipolar Coagulation Forceps, Model 824XXXXX
Summary page 1
…ps (K051429) BiTech Bipolar Scissors (K042077) POWERGRIP Bipolar Coagulation Forceps (K033177) Bissinger Cables (K981919) Bissinger Detachable Bipolar Coagulation…
Gunter Bissinger Medizintechnik GmbH2004—
*K981919Bissinger Cables, Cat. NO. 801000XX
Summary page 1
…Scissors (K042077) POWERGRIP Bipolar Coagulation Forceps (K033177) Bissinger Cables (K981919) Bissinger Detachable Bipolar Coagulation Forceps (K970968) Intende…
Guenter Bissinger Medizintechnik GmbH1998—
*K970968Bissinger Detachable Bipolar Coagulation-Forceps
Summary page 1
…3177) Bissinger Cables (K981919) Bissinger Detachable Bipolar Coagulation Forceps (K970968) Intended Use: KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipola…
Guenter Bissinger Medizintechnik GmbH1998—

Also cleared against K051429: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 17 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
  • 1 of the 17 ancestors has a recall of any class.
  • 7 other devices also cite its predicate K051429.

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. 2009, 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?

KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures. KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures. KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and…

Read the full statement (136 words)

KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.

KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.

KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.

KLS Martin Bipolar Forceps/Non-Stick are design to grasp, manipulate and coagulate selected tissue.

KLS Martin Electrosurgical Instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures

KLS Martin Electrosurgical cables are intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar electrosurgical generator to a bipolar instrument.

Indications for use as stated in the FDA summary.

Also cleared against K051429

7 other devices cite the same predicate.

  • K213042Supra Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2022
  • K131012Sutter Bipolar Forceps - SuperglissSutter Medizintechnik GmbH · 2013
  • K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
  • K073498Laparoscopic and Electrosurgical Instruments and Accessories, Laparoscopy Rudolf SystemRudolf Medical GmbH + Co. KG · 2008
  • K070997Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar Reusable Cables, Model 5015-XXPro-Med Instruments GmbH · 2007
  • K061635MSD Bipolar ForcepsMedtronic Sofamor Danek · 2006

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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  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K082505 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082505: KLS Martin Electrosurgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082505

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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