510(k) · Cleared
Recalled · Class II · 2018Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olsen Medical · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Dec 6, 2013 as substantially equivalent to K884656 (Dermacare, 1988) and 3 other predicates after a 269-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 6, 2013
- Review
- 269 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 7 generations to K923332 (1992). 12 ancestors in all, the oldest K884656 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 6 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 5 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- 4 generations backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
- 3 generations backK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
- 2 generations backK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · Recalled
- 1 generation backK093108 Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010
- This deviceK130669 Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use…Olsen Medical · 2013
- Descendant · cites it directly · 0 of its ownK210315 Single Use Hand Switch Monopolar Forceps with Smoke Evacuation…Modern Medical Equipment Manufacturing, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K210315Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch…Modern Medical Equipment Manufacturing, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −6 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −5 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| −4 | K051429 | Claris Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | 2005 | — |
| −3 | K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar… | Pro-Med Instruments GmbH | 2007 | — |
| −2 | K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products, Inc. | 2009 | 1 |
| −1 | K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co KG | 2010 | — |
| 0 (this device) | K130669 | Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar… | Olsen Medical | 2013 | — |
| +1 | K210315 | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use… | Modern Medical Equipment Manufacturing, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K884656 | Disposable Bipolar Cord and Bipolar ForcepSummary page 1…Bip~olar Forceps: Dermacare (now Olsen Medical) Disposable Bipolar Cord and Bipolar Forcep, K884656, cleared November 25, 1988 Olsen Medical Midas Touch Bipolar Forc… | 1988 |
| * | K982705 | Midas Touch Bipolar ForcepsSummary page 1…656, cleared November 25, 1988 Olsen Medical Midas Touch Bipolar Forceps, K982705, cleared September 8, 1998 Stryker Bipolar Forceps, K093 108, cleared June… | 1998 |
| * | K093108 | Stryker Bipolar ForcepsSummary page 1…Olsen Medical Midas Touch Bipolar Forceps, K982705, cleared September 8, 1998 Stryker Bipolar Forceps, K093 108, cleared June 22, 2010 K130669… | 2010 |
| * | K950877 | Reusable Monopolar ForcepsSummary page 2…Monopolar Forceps: Boston Surgical Products Reusable Monopolar Forceps, K950877, cleared March 9, 1995 Device Description: OLSENMedical® Electrosurgical Monopolar and Bipolar Forceps have been designed as act… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210315 | Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch… | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2018 | Class II | Z-1944-2018 | Package design/selection | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 8 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K210315 (Modern Medical Equipment Manufacturing, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K884656.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130669 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130669: Single Use & Multi Use Bipolar Forceps / Single Use & Multi Use Monopolar Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130669
Report an extraction error
Are you the manufacturer?
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