510(k) · Cleared
ClearedHet Bipolar Ligator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Het Systems, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 20, 2012 as substantially equivalent to K110143 (Het Systems, LLC, 2011) and 1 other predicate after a 224-day review. Its family tree reaches back 8 generations to 1992. 2 later devices descend from it.
- Decided
- Nov 20, 2012
- Review
- 224 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K923332 (1992). 26 ancestors in all, the oldest K904646 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK923332 Electrosurgical ElectrodesPremier Dental Products Co. · 1992
- 7 generations backK970987 Electrosurgical ElectrodeFusion Medical Technologies, Inc. · 1997
- 6 generations backK992931 Non-Stick Bipolar ForcepsSilverglide Surgical Technologies · 1999
- 5 generations backK051429 Claris Non-Stick Bipolar ForcepsGuenter Bissinger Medizintechnik GmbH · 2005
- 4 generations backK070997 Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro…Pro-Med Instruments GmbH · 2007
- 3 generations backK083162 Stingray Electrosurgical ForcepsStingray Surgical Products, Inc. · 2009 · Recalled
- 2 generations backK093108 Stryker Bipolar ForcepsStryker Leibinger GmbH & Co KG · 2010
- 1 generation backK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
- This deviceK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
- Descendant · cites it directly · 1 of its ownK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K923332 | Electrosurgical Electrodes | Premier Dental Products Co. | 1992 | — |
| −7 | K970987 | Electrosurgical Electrode | Fusion Medical Technologies, Inc. | 1997 | — |
| −6 | K992931 | Non-Stick Bipolar Forceps | Silverglide Surgical Technologies | 1999 | — |
| −5 | K051429 | Claris Non-Stick Bipolar Forceps | Guenter Bissinger Medizintechnik GmbH | 2005 | — |
| −4 | K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-XX to 5012-XX, Doro Bipolar… | Pro-Med Instruments GmbH | 2007 | — |
| −3 | K083162 | Stingray Electrosurgical Forceps | Stingray Surgical Products, Inc. | 2009 | 1 |
| −2 | K093108 | Stryker Bipolar Forceps | Stryker Leibinger GmbH & Co KG | 2010 | — |
| −1 | K110143 | Het Bipolar Electrocautery Forceps | Het Systems, LLC | 2011 | — |
| 0 (this device) | K121085 | Het Bipolar Ligator System | Het Systems, LLC | 2012 | — |
| +1 | K140422 | Het Systems, LLC, Het Bipolar Ligator System | Het Systems, LLC | 2014 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K110143 | Het Bipolar Electrocautery ForcepsSummary page 1…CFR 875.4400 Predicate Devices HET TM Bipolar Electrocautery Forceps and Monitor HET Systems, Inc. 510O(k) K1 10143 Redfield Infrared Coagulator Redfield, Inc. 510(k) K950836 === Page… | 2011 |
| * | K950836 | Redfield Infrared CoagulatorSummary page 1…HET Systems, Inc. 510O(k) K1 10143 Redfield Infrared Coagulator Redfield, Inc. 510(k) K950836 Description The HETTM Bipolar Electrocautery System is comprised of the HETTM Bipolar Forceps and the HETTM Moni… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140422 | Het Systems, LLC, Het Bipolar Ligator System | 2014 | 1 |
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 20 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K140422 (Het Systems, LLC, 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Electrocautery Forceps and Monitor are intended to be used for
grasping, manipulating and coagulating soft tissue during general surgery.
The HET™ Bipolar Electrocautery Forceps and Monitor may be used for the treatment
of symptomatic Grade I and Grade II internal hemorrhoids.
The accessory monitor provides power for a temperature sensor and an LED light
source mounted on the disposable forceps. The HET Bipolar Electrocautery Forceps
and Monitor may be used with the CONMED HYFRECATOR® 2000 or VALLEYLAB
SURGISTAT 11RF energy generators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121085 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121085: Het Bipolar Ligator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121085
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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