510(k) Report

510(k) · Cleared

Cleared

HALO360' Coagulation Catheter

K071543510(k) SpecialCleared Jun 29, 200724-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Barrx Medical, Incorporated · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jun 29, 2007 as substantially equivalent to K051168 (Barrx Medical, Incorporated, 2005) and 1 other predicate after a 24-day review. Its family tree reaches back 14 generations to 1995. 19 later devices descend from it.

Decided
Jun 29, 2007
Review
24 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
2

Its longest line of descent runs back 14 generations to K943450 (1995). 32 ancestors in all, the oldest K800617 (1980). 19 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1998: 2 other ancestors1997: 1 other ancestor1996: 5 other ancestors1994: 1 other ancestor1992: 1 other ancestor1984: 1 other ancestor1986: 1 other ancestor1985: 1 other ancestor1980: 1 other ancestor1995: 1 other ancestor2009: 1 descendant cleared2010: 3 descendants cleared2008: 1 descendant cleared2014: 2 descendants cleared2012: 2 descendants cleared2019: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant cleared2015: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) ×2: 2 generations cleared close together, K964849 (1997), K971532 (1997) K013139 · Stellartech Coagulation System · Stellartech Research Corp. · 2001×3: 3 generations cleared close together, K032062 (2003), K032452 (2003), K032721 (2003) ×4: 4 generations cleared close together, K040240 (2004), K041383 (2004), K042909 (2004), K050831 (2005) K062225 · Halo Coagulation Catheter · Barrx Medical, Incorporated · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor4 generations back: 8 other ancestors5 generations back: 5 other ancestors6 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 8 descendants K062225 · Halo Coagulation Catheter · Barrx Medical, Incorporated · 2006K050831 · Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230A · Stellartech Research Corp. · 2005K042909 · Stellartech Coagulation System, Models 1100C-115A & 1100C-230A · Stellartech Research Corp. · 2004K041383 · Stellartech Coagulation System, Models 1100C-115 and 1100C-230 · Stellartech Research Corp. · 2004K040240 · Stellartech Coagulation System (Models 1100C-115 & 1100C-230) · Stellartech Research Corp. · 2004K032721 · Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230) · Stellartech Research Corp. · 2003K032452 · Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230 · Stellartech Research Corp. · 2003K032062 · Stellartech Coagulation System, Models (1100C-115 & 1100C-230) · Stellartech Research Corp. · 2003K013139 · Stellartech Coagulation System · Stellartech Research Corp. · 2001K971532 · Arthrocare Electrosurgery System · Arthrocare Corp. · 1997K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−10−50
  1. Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 10 generations between
  3. 3 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
  4. 2 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
  5. 1 generation backK062225 Halo Coagulation CatheterBarrx Medical, Incorporated · 2006
  6. This deviceK071543 HALO360' Coagulation CatheterBarrx Medical, Incorporated · 2007
  7. Descendant · cites it directly · 17 of its ownK083711 Modification to: Halo Coagulation Catheter, Models 32041-18…Barrx Medical, Incorporated · 2009
  8. Descendant · 2 generations on · 14 of its ownK093008 Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
  9. Descendant · 3 generations on · 4 of its ownK183595 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019
  10. Descendant · 3 generations on · 4 of its ownK112454 HALO60 Ablation CatheterBarrx Medical, Inc. · 2012
  11. Descendant · 4 generations on · 3 of its ownK211282 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2021
Show all 14 generations
  1. Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 10 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. 9 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
  7. 8 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
  8. 7 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
  9. 6 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
  10. 5 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
  11. 4 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
  12. 3 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
  13. 2 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
  14. 1 generation backK062225 Halo Coagulation CatheterBarrx Medical, Incorporated · 2006
  15. This deviceK071543 HALO360' Coagulation CatheterBarrx Medical, Incorporated · 2007

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 32012: 22013: 12014: 22015: 12016: 12017: 12018: 12019: 12021: 22024: 12025: 1
2008high 3 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 19 · See all
  • K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated · 2009 · cites it directly17descendants
  • K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010 · 2 generations on14descendants
  • K183595Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019 · 3 generations on4descendants
  • K112454HALO60 Ablation CatheterBarrx Medical, Inc. · 2012 · 3 generations on4descendants
  • K211282Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2021 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−13K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−12K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−11K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−10K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
−9K013139Stellartech Coagulation SystemStellartech Research Corp.2001—
−8K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.2003—
−7K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.2003—
−6K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2003—
−5K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2004—
−4K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.2004—
−3K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.2004—
−2K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.2005—
−1K062225Halo Coagulation CatheterBarrx Medical, Incorporated2006—
0 (this device)K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated2007—
+1K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20…Barrx Medical, Incorporated2009—
+2K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated2010—
+3K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.2019—
+3K112454HALO60 Ablation CatheterBarrx Medical, Inc.2012—
+4K211282Aqua Medical RF Vapor SystemAqua Medical, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198410
198510
198610
199210
199410
199510
199650
199710
199820
200010
200210
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201030
201220
201310
201420
201510
201610
201710
201810
201910
202120
202410
202510
FIG. 1 — Lineage of K071543, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K051168Barrx Halo 360 System, Model 1100C-115A
Summary page 2
…Page: 18 RARRiX Wtdiesj] iti 5101' Predicate Device(s) ITC K051168 IIALO360 Coagulation System-BARRX Medical Inc. K062225 HALO 360 Coagulation Catheter-BARRX Medical Inc. Intended Use I I…
Barrx Medical, Incorporated2005—
*K062225Halo Coagulation Catheter
Summary page 2
…iti 5101' Predicate Device(s) ITC K051168 IIALO360 Coagulation System-BARRX Medical Inc. K062225 HALO 360 Coagulation Catheter-BARRX Medical Inc. Intended Use I Indications for Use The HALO36O+ Coagulation Catheter model is…
Barrx Medical, Incorporated2006—

Also cleared against K051168: 8 other devices →

What descends from it? (19)

See all 19

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22…Barrx Medical, Incorporated200917
K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103
K080557Barrx Models HALO360 and HALO360+ Coagulation CathetersBarrx Medical, Incorporated20080

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 12 years and passes through 3 companies; a new generation was cleared every 6 months on median.
  • 1 of the 32 ancestors has a recall of any class.
  • Of its descendants, K083711 (Barrx Medical, Incorporated, 2009) has gone furthest, with 17 descendants of its own.
  • 8 other devices also cite its predicate K051168.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

What is it indicated for?

The HALO 360+ Coagulation Catheter 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.

Also cleared against K051168

8 other devices cite the same predicate.

  • K101825Cryoballoon Ablation SystemC2 Therapeutics · 2010
  • K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated · 2010
  • K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
  • K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated · 20091 recall
  • K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated · 2008
  • K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010; Footswitch, Model…Barrx Medical, Incorporated · 2006

More from Barrx Medical, Incorporated

13 FDA decisions under this applicant name. See the company

  • K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated · 2010
  • K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
  • K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated · 20091 recall
  • K083737Halo Ablation CatheterBarrx Medical, Incorporated · 2009
  • K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28…Barrx Medical, Incorporated · 2009

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https://510kreport.com/device/K071543 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071543: HALO360' Coagulation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071543

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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