510(k) Report

510(k) · Cleared

Cleared

Barrx Halo 360 System, Model 1100C-115A

K051168510(k) TraditionalCleared Jun 29, 200555-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, 2005 after a 55-day review. The FDA summary names its predicate without a number. 39 later devices descend from it.

Decided
Jun 29, 2005
Review
55 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
0

39 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared2007: 1 descendant cleared2006: 4 descendants cleared2010: 4 descendants cleared2008: 2 descendants cleared2019: 2 descendants cleared2014: 2 descendants cleared2012: 2 descendants cleared2013: 2 descendants cleared2015: 2 descendants cleared2017: 2 descendants cleared2018: 2 descendants cleared2016: 4 descendants cleared2024: 2 descendants cleared2021: 3 descendants cleared2025: 1 descendant cleared2020: 1 descendant cleared20052010201520202025
  1. This deviceK051168 Barrx Halo 360 System, Model 1100C-115ABarrx Medical, Incorporated · 2005
  2. Descendant · cites it directly · 29 of its ownK060169 Barrx Halo Coagulation System, Barrx Halo Coagulation Generator…Barrx Medical, Incorporated · 2006
  3. Descendant · 2 generations on · 26 of its ownK062723 HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006
  4. Descendant · 3 generations on · 22 of its ownK083737 Halo Ablation CatheterBarrx Medical, Incorporated · 2009
  5. Descendant · cites it directly · 20 of its ownK062225 Halo Coagulation CatheterBarrx Medical, Incorporated · 2006
  6. Descendant · cites it directly · 19 of its ownK071543 HALO360' Coagulation CatheterBarrx Medical, Incorporated · 2007

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2006: 42007: 12008: 22009: 32010: 42012: 22013: 22014: 22015: 22016: 42017: 22018: 22019: 22020: 12021: 32024: 22025: 1
2006high 4 (2006) · low 0 (2011)2026

Most influential descendants

Showing 5 of 39 · See all
  • K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated · 2006 · cites it directly29descendants
  • K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated · 2006 · 2 generations on26descendants
  • K083737Halo Ablation CatheterBarrx Medical, Incorporated · 2009 · 3 generations on22descendants
  • K062225Halo Coagulation CatheterBarrx Medical, Incorporated · 2006 · cites it directly20descendants
  • K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated · 2007 · cites it directly19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051168Barrx Halo 360 System, Model 1100C-115ABarrx Medical, Incorporated2005—
+1K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx…Barrx Medical, Incorporated2006—
+2K062723HALO90 Coagulation CatheterBarrx Medical, Incorporated2006—
+3K083737Halo Ablation CatheterBarrx Medical, Incorporated2009—
+1K062225Halo Coagulation CatheterBarrx Medical, Incorporated2006—
+1K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200640
200710
200820
200930
201040
201220
201320
201420
201520
201640
201720
201820
201920
202010
202130
202420
202510
FIG. 1 — Lineage of K051168, 2005–2025Source: 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
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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
*—Stellartech Coagulation System 2
Named without a submission number
—

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K060169Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation…Barrx Medical, Incorporated200629
K062225Halo Coagulation CatheterBarrx Medical, Incorporated200620
K071543HALO360' Coagulation CatheterBarrx Medical, Incorporated200719
K093008Halo Ablation Catheter, Model 90-9100Barrx Medical, Incorporated201014
K101825Cryoballoon Ablation SystemC2 Therapeutics201011
K093855Halo 360 & Sizing Balloon, Model 3441CBarrx Medical, Incorporated20103
K062441Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010…Barrx Medical, Incorporated20063
K092487Haloflex Energy Generator, Models 1190A-115A and 1190A-230ABarrx Medical, Incorporated20092
K082202HALO360 Energy Generator, Models 1100C-115B and 1100C-230BBarrx 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?

  • Of its descendants, K060169 (Barrx Medical, Incorporated, 2006) has gone furthest, with 29 descendants of its own.

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.

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 System 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.

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/K051168 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051168: Barrx Halo 360 System, Model 1100C-115A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051168

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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