510(k) · Cleared
ClearedHalo 360 & Sizing Balloon, Model 3441C
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 Jan 15, 2010 as substantially equivalent to K051168 (Barrx Medical, Incorporated, 2005) and 2 other predicates after a 30-day review. Its family tree reaches back 16 generations to 1995. 3 later devices descend from it.
- Decided
- Jan 15, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K943450 (1995). 36 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
- 2 generations backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
- 1 generation backK083711 Modification to: Halo Coagulation Catheter, Models 32041-18…Barrx Medical, Incorporated · 2009
- This deviceK093855 Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated · 2010
- 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
- Descendant · cites it directly · 0 of its ownK142364 Barrx RFA Self Sizing Balloon CatheterCovidien, LLC · 2014
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
- 10 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
- 9 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
- 8 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
- 7 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
- 6 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
- 5 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
- 4 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
- 3 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
- 2 generations backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
- 1 generation backK083711 Modification to: Halo Coagulation Catheter, Models 32041-18…Barrx Medical, Incorporated · 2009
- This deviceK093855 Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K013139 | Stellartech Coagulation System | Stellartech Research Corp. | 2001 | — |
| −10 | K032062 | Stellartech Coagulation System, Models (1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −9 | K032452 | Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 | Stellartech Research Corp. | 2003 | — |
| −8 | K032721 | Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −7 | K040240 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2004 | — |
| −6 | K041383 | Stellartech Coagulation System, Models 1100C-115 and 1100C-230 | Stellartech Research Corp. | 2004 | — |
| −5 | K042909 | Stellartech Coagulation System, Models 1100C-115A & 1100C-230A | Stellartech Research Corp. | 2004 | — |
| −4 | K050831 | Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A | Stellartech Research Corp. | 2005 | — |
| −3 | K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx… | Barrx Medical, Incorporated | 2006 | — |
| −2 | K062723 | HALO90 Coagulation Catheter | Barrx Medical, Incorporated | 2006 | — |
| −1 | K083711 | Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20… | Barrx Medical, Incorporated | 2009 | — |
| 0 (this device) | K093855 | Halo 360 & Sizing Balloon, Model 3441C | Barrx Medical, Incorporated | 2010 | — |
| +1 | K141357 | Barrx Flex Rfa Energy Generator | Covidien Iic | 2014 | — |
| +2 | K160360 | Barrx FLEX RFA Energy Generator | Covidien, LLC | 2016 | — |
| +1 | K142364 | Barrx RFA Self Sizing Balloon Catheter | Covidien, LLC | 2014 | — |
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 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 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? (3)
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 1…& accessories Device Class: II Classification panel: General & Plastic Surgery Predicate Devices HALOOO( Sizing Balloon model 3441B (K(051168) HALO36+ Ablation Catheter model 32041-XX (1(0837 11, KO'71543) Purpose of therSpecial 5 10(k) notice. The… | 2005 |
| * | K083711 | Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22… | 2009 |
| * | K071543 | HALO360' Coagulation Catheter | 2007 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 1 of the 36 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. 2010, 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?
HALO360+ Sizing Balloon model 3441C is indicated for 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/K093855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093855: Halo 360 & Sizing Balloon, Model 3441C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093855
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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