# K120431: HALO90 Ultra Ablation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Barrx Medical, Inc.
- Decided: May 3, 2012 after 80 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101111: Halo Ablation Catheter Model 90-9100, HALO90 Ultra Ablation Catheter Model 90-9200, Barrx Medical, Inc. (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K112545: Quanta Flash PR3, Quanta Flash Mpo, Quanta Flash GBM, Inova Diagnostics, Inc. (2012). Our reading of the summary gave K112545, which FDA decided on Jul 31, 2012, after this device was decided (May 3, 2012), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1.

## Indications for use
The HAO"ULTRA Ablation Catheter (used with the HALOLEx 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 (RP1).

Source page: https://510kreport.com/device/K120431
Methodology: https://510kreport.com/methodology