510(k) Report

510(k) · Cleared

Cleared

Halo Ablation Catheter

K083737510(k) SpecialCleared Feb 10, 200956-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 Feb 10, 2009 as substantially equivalent to K062723 (Barrx Medical, Incorporated, 2006) after a 56-day review. Its family tree reaches back 15 generations to 1995. 22 later devices descend from it.

Decided
Feb 10, 2009
Review
56 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 15 generations to K943450 (1995). 33 ancestors in all, the oldest K800617 (1980). 22 later devices descend from it, 4 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 ancestor2012: 2 descendants cleared2016: 2 descendants cleared2010: 2 descendants cleared2014: 1 descendant cleared2019: 2 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2017: 2 descendants cleared2018: 2 descendants cleared2024: 2 descendants cleared2021: 3 descendants cleared2025: 1 descendant cleared2020: 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) K060169 · Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F · Barrx Medical, Incorporated · 2006K062723 · HALO90 Coagulation Catheter · Barrx Medical, Incorporated · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 8 other ancestors6 generations back: 5 other ancestors7 generations back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 8 descendants3 generations forward: 7 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K062723 · HALO90 Coagulation Catheter · Barrx Medical, Incorporated · 2006K060169 · Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F · 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. · 1995−15−10−50+5
  1. Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 11 generations between
  3. 3 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
  4. 2 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
  5. 1 generation backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
  6. This deviceK083737 Halo Ablation CatheterBarrx Medical, Incorporated · 2009
  7. Descendant · cites it directly · 14 of its ownK093008 Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
  8. Descendant · cites it directly · 6 of its ownK152329 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System…C2 Therapeutics, Inc. · 2016 · Recalled
  9. Descendant · 2 generations on · 5 of its ownK161202 C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · Recalled
  10. Descendant · 2 generations on · 4 of its ownK183595 Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019
  11. Descendant · 2 generations on · 4 of its ownK163684 C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018 · Recalled
Show all 15 generations
  1. Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 11 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. 10 generations backK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
  7. 9 generations backK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
  8. 8 generations backK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
  9. 7 generations backK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003
  10. 6 generations backK040240 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2004
  11. 5 generations backK041383 Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp. · 2004
  12. 4 generations backK042909 Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp. · 2004
  13. 3 generations backK050831 Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp. · 2005
  14. 2 generations backK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
  15. 1 generation backK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
  16. This deviceK083737 Halo Ablation CatheterBarrx Medical, Incorporated · 2009

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2010: 22012: 22013: 12014: 12015: 12016: 22017: 22018: 22019: 22020: 12021: 32024: 22025: 1
2010high 3 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 22 · See all
  • K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010 · cites it directly14descendants
  • K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc. · 2016 · cites it directly6descendants
  • K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 2017 · 2 generations on5descendants
  • K183595Aqua Medical RF Vapor SystemAqua Medical, Inc. · 2019 · 2 generations on4descendants
  • K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2018 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−14K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−13K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−12K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−11K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
−10K013139Stellartech Coagulation SystemStellartech Research Corp.2001—
−9K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.2003—
−8K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.2003—
−7K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2003—
−6K040240Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2004—
−5K041383Stellartech Coagulation System, Models 1100C-115 and 1100C-230Stellartech Research Corp.2004—
−4K042909Stellartech Coagulation System, Models 1100C-115A & 1100C-230AStellartech Research Corp.2004—
−3K050831Stellartech Coagulation System 2, Models 1100C-115A and 1100C-230AStellartech Research Corp.2005—
−2K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx…Barrx Medical, Incorporated2006—
−1K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated2006—
0 (this device)K083737Halo Ablation CatheterBarrx Medical, Incorporated2009—
+1K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated2010—
+1K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe…C2 Therapeutics, Inc.20161
+2K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.20171
+2K183595Aqua Medical RF Vapor SystemAqua Medical, Inc.2019—
+2K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.20184

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
201020
201220
201310
201410
201510
201620
201720
201820
201920
202010
202130
202420
202510
FIG. 1 — Lineage of K083737, 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? (1)

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
*K062723HALO90 Coagulation Catheter
Summary page 1
…Device Class: II Classification panel: General & Plastic Surgery 5. Predicate Devices HALO 90 Coagulation Catheter model 90-9100 (K(062723) manufactured by BARRX Medical Inc. HAL090 Ablation Catheter 27 === Page…
Barrx Medical, Incorporated2006—

Also cleared against K062723: 4 other devices →

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014
K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.20166
K112454HALO60 Ablation CatheterBarrx Medical, Inc.20124
K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc.20101

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 14 years and passes through 3 companies; a new generation was cleared every 6 months on median.
  • 1 of the 33 ancestors has a recall of any class.
  • Of its descendants, K093008 (Barrx Medical, Incorporated, 2010) has gone furthest, with 14 descendants of its own.
  • 4 other devices also cite its predicate K062723.

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. 2009, 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 90 System (inclusive of HALO 90 Ablation 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 K062723

4 other devices cite the same predicate.

  • K112454HALO60 Ablation CatheterBarrx Medical, Inc. · 2012
  • K101111Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200Barrx Medical, Inc. · 20101 recall
  • K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated · 2010
  • K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28…Barrx Medical, Incorporated · 2009

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
  • K083711Modification to: Halo Coagulation Catheter, Models 32041-18, 32041-20, 32041-22, 32041-25, 32041-28…Barrx Medical, Incorporated · 2009
  • K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx Medical, Incorporated · 2008

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The GEI category page

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https://510kreport.com/device/K083737 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083737: Halo Ablation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083737

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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