510(k) · Cleared
ClearedHALO60 Ablation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barrx Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 5, 2012 as substantially equivalent to K093008 (Barrx Medical, Incorporated, 2010) and 2 other predicates after a 133-day review. Its family tree reaches back 17 generations to 1995. 4 later devices descend from it.
- Decided
- Jan 5, 2012
- Review
- 133 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K943450 (1995). 40 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 3 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
- 2 generations backK083711 Modification to: Halo Coagulation Catheter, Models 32041-18…Barrx Medical, Incorporated · 2009
- 1 generation backK093008 Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
- This deviceK112454 HALO60 Ablation CatheterBarrx Medical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK150251 Barrx Anorectal RFA WandCovidien, LLC · 2015
- Descendant · cites it directly · 1 of its ownK130623 Barrx Channel Rfa Endoscopic CatheterCovidien, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK173559 Barrx SB RFA Endoscopic CatheterCovidien, LLC · 2018
- Descendant · cites it directly · 0 of its ownK162802 Barrx Anorectal RFA WandCovidien, LLC · 2017
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
- 11 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
- 10 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
- 9 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
- 8 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
- 7 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
- 6 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
- 5 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
- 4 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
- 3 generations backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
- 2 generations backK083711 Modification to: Halo Coagulation Catheter, Models 32041-18…Barrx Medical, Incorporated · 2009
- 1 generation backK093008 Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
- This deviceK112454 HALO60 Ablation CatheterBarrx Medical, Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K150251Barrx Anorectal RFA WandCovidien, LLC · 2015 · cites it directly1descendant
- K130623Barrx Channel Rfa Endoscopic CatheterCovidien, LLC · 2013 · cites it directly1descendant
- K173559Barrx SB RFA Endoscopic CatheterCovidien, LLC · 2018 · 2 generations on0descendants
- K162802Barrx Anorectal RFA WandCovidien, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K013139 | Stellartech Coagulation System | Stellartech Research Corp. | 2001 | — |
| −11 | K032062 | Stellartech Coagulation System, Models (1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −10 | K032452 | Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 | Stellartech Research Corp. | 2003 | — |
| −9 | K032721 | Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003 | — |
| −8 | K040240 | Stellartech Coagulation System (Models 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2004 | — |
| −7 | K041383 | Stellartech Coagulation System, Models 1100C-115 and 1100C-230 | Stellartech Research Corp. | 2004 | — |
| −6 | K042909 | Stellartech Coagulation System, Models 1100C-115A & 1100C-230A | Stellartech Research Corp. | 2004 | — |
| −5 | K050831 | Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A | Stellartech Research Corp. | 2005 | — |
| −4 | K060169 | Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx… | Barrx Medical, Incorporated | 2006 | — |
| −3 | K062723 | HALO90 Coagulation Catheter | Barrx Medical, Incorporated | 2006 | — |
| −2 | K083711 | Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20… | Barrx Medical, Incorporated | 2009 | — |
| −1 | K093008 | Halo Ablation Catheter, Model 90-9100 | Barrx Medical, Incorporated | 2010 | — |
| 0 (this device) | K112454 | HALO60 Ablation Catheter | Barrx Medical, Inc. | 2012 | — |
| +1 | K150251 | Barrx Anorectal RFA Wand | Covidien, LLC | 2015 | — |
| +1 | K130623 | Barrx Channel Rfa Endoscopic Catheter | Covidien, LLC | 2013 | — |
| +2 | K173559 | Barrx SB RFA Endoscopic Catheter | Covidien, LLC | 2018 | — |
| +1 | K162802 | Barrx Anorectal RFA Wand | Covidien, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K093008 | Halo Ablation Catheter, Model 90-9100Summary page 1…g and Coagulation Devices and Accessories (21 CFR 878.4400, Product Code GEl) PREDICATE DEVICE HALO 90 Ablation Catheter (model 90-9100, cleared by the FDA under K093008, K(083737, and K(062723). OVERVIEW The HALO60 Ablation Catheter (subject device, hereafter referred to as "HALO'O") is a… | 2010 |
| * | K083737 | Halo Ablation CatheterSummary page 3…IAL EQUIVALENCE DISCUSSION As mentioned earlier, the HALO60 (subject device) is a modification of the HALO90 (predicate device), cleared by the FDA under K(093008, K083737, and K(062723. The primary modification is a dimensional reduction of the copper electrode surface area, from 2.6cm 2 (1.3… | 2009 |
| * | K062723 | HALO90 Coagulation CatheterSummary page 1…d Accessories (21 CFR 878.4400, Product Code GEl) PREDICATE DEVICE HALO 90 Ablation Catheter (model 90-9100, cleared by the FDA under K093008, K(083737, and K(062723). OVERVIEW The HALO60 Ablation Catheter (subject device, hereafter referred to as "HALO'O") is a single-use bipolar devic… | 2006 |
What descends from it? (4)
3 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 17 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 1 of the 40 ancestors has a recall of any class.
- Of its descendants, K150251 (Covidien, LLC, 2015) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K093008.
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 HALO60 Ablation Catheter (used with the HALOFLEX Energy Generator, model 1190A-115A) 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, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (11P).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112454: HALO60 Ablation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112454
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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