510(k) · Cleared
ClearedHET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 7, 2020 as substantially equivalent to K140422 (Het Systems, LLC, 2014) after a 106-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- May 7, 2020
- Review
- 106 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K923332 (1992). 28 ancestors in all, the oldest K904646 (1991). No later device cites it as a predicate yet.
- Root · 10 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 6 generations between
- 3 generations backK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
- 2 generations backK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
- 1 generation backK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
- This deviceK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020
Show all 10 generations
- Root · 10 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 9 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 8 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- 7 generations backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
- 6 generations backK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
- 5 generations backK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · Recalled
- 4 generations backK093108 Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010
- 3 generations backK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
- 2 generations backK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
- 1 generation backK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
- This deviceK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −9 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −8 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| −7 | K051429 | Claris Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | 2005 | — |
| −6 | K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar… | Pro-Med Instruments GmbH | 2007 | — |
| −5 | K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products, Inc. | 2009 | 1 |
| −4 | K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co KG | 2010 | — |
| −3 | K110143 | Het Bipolar Electrocautery Forceps | Het Systems, LLC | 2011 | — |
| −2 | K121085 | Het Bipolar Ligator System | Het Systems, LLC | 2012 | — |
| −1 | K140422 | Het Systems, LLC, Het Bipolar Ligator System | Het Systems, LLC | 2014 | — |
| 0 (this device) | K200146 | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor | Covidien, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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? (1)
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 |
|---|---|---|---|
| * | K140422 | Het Systems, LLC, Het Bipolar Ligator SystemSummary page 4…Road – Unit 3e Oxford, CT 06478 The CMM facility has been assigned establishment registration number 3006183537 and Owner/Operator number 10042275. Predicate Device(s): K140422 HET™ Bipolar Electrocautery Forceps and Monitor Device Description: The HET™ Bipolar Forceps is a sterile, single-use bipolar fo… | 2014 |
| † | K121085 | Het Bipolar Ligator System | 2012 |
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 28 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 28 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 HET Bipolar System is intended to be used for the treatment of symptomatic grade I and grade II internal hemorrhoids.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200146: HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200146
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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