510(k) · Cleared
Recalled · Class II · 2012Haloflex Energy Generator, Models 1190A-115A and 1190A-230A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barrx Medical, Incorporated · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 10, 2009 as substantially equivalent to K051168 (Barrx Medical, Incorporated, 2005) and 3 other predicates after an 89-day review. Its family tree reaches back 15 generations to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 10, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 15 generations to K943450 (1995). 34 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
- 2 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
- 1 generation backK062441 Barrx Halo Coagulation System; Generator, Model 90-9000; Output…Barrx Medical, Incorporated · 2006
- This deviceK092487 Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated · 2009
- Descendant · cites it directly · 1 of its ownK141357 Barrx Flex Rfa Energy GeneratorCovidien Iic · 2014
- Descendant · 2 generations on · 0 of its ownK160360 Barrx FLEX RFA Energy GeneratorCovidien, LLC · 2016
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
- 9 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
- 8 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
- 7 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
- 6 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
- 5 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
- 4 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
- 3 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
- 2 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
- 1 generation backK062441 Barrx Halo Coagulation System; Generator, Model 90-9000; Output…Barrx Medical, Incorporated · 2006
- This deviceK092487 Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated · 2009
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 |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K013139 | Stellartech Coagulation System | Stellartech Research Corp. | 2001 | — |
| −9 | K032062 | Stellartech Coagulation System, Models (1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −8 | K032452 | Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 | Stellartech Research Corp. | 2003 | — |
| −7 | K032721 | Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −6 | K040240 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2004 | — |
| −5 | K041383 | Stellartech Coagulation System, Models 1100C-115 and 1100C-230 | Stellartech Research Corp. | 2004 | — |
| −4 | K042909 | Stellartech Coagulation System, Models 1100C-115A & 1100C-230A | Stellartech Research Corp. | 2004 | — |
| −3 | K050831 | Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A | Stellartech Research Corp. | 2005 | — |
| −2 | K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx… | Barrx Medical, Incorporated | 2006 | — |
| −1 | K062441 | Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model… | Barrx Medical, Incorporated | 2006 | — |
| 0 (this device) | K092487 | Haloflex Energy Generator, Models 1190A-115A and 1190A-230A | Barrx Medical, Incorporated | 2009 | — |
| +1 | K141357 | Barrx Flex Rfa Energy Generator | Covidien Iic | 2014 | — |
| +2 | K160360 | Barrx FLEX RFA Energy Generator | Covidien, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K051168 | Barrx Halo 360 System, Model 1100C-115ASummary page 2…dministration ("FDA" or the "Agency") for use in coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus (K051168 and K060169, K062441 respectively). The Generator has the same intended use and fundamental scientific technology as the cleared… | 2005 |
| * | K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Summary page 2…n ("FDA" or the "Agency") for use in coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus (K051168 and K060169, K062441 respectively). The Generator has the same intended use and fundamental scientific technology as the cleared HALO 360 and… | 2006 |
| * | K062441 | Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Summary page 2…or the "Agency") for use in coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus (K051168 and K060169, K062441 respectively). The Generator has the same intended use and fundamental scientific technology as the cleared HALO 360 and HALO 90… | 2006 |
| * | K000241 | Radiotherapeutics RF 3000 Radiofrequency GeneratorSummary page 2…ddition, the intended use was expanded to include "coagulation of soft tissue", for this indication for use the predicate device is the RF 3000 Radiofrequency Generator (K000241). The design changes between the HALO 36o and HALO09 Energy Generators and the HALOFLEx Energy Generator do… | 2000 |
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 |
|---|---|---|---|
| K141357 | Barrx Flex Rfa Energy Generator | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2012 | Class II | Z-2379-2012 | Software design | Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K141357 (Covidien Iic, 2014) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K051168.
How does its category compare?
All GEI devicesGEI 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
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 HALOFLEX Energy Generator is indicated for use for the coagulation of soft tissue.
The HALOFLEX Energy Generator is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including, but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092487 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092487: Haloflex Energy Generator, Models 1190A-115A and 1190A-230A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092487
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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