# K092487: Haloflex Energy Generator, Models 1190A-115A and 1190A-230A

- Pathway: 510(k) (Traditional)
- Applicant: Barrx Medical, Incorporated
- Decided: Nov 10, 2009 after 89 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 34 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051168: Barrx Halo 360 System, Model 1100C-115A, Barrx Medical, Incorporated (2005) Summary page 2.
- K060169: Barrx Halo Coagulation System, Barrx Halo Coagulation Generator, Barrx Coagulation Catheter, Models 2200-115A, 1520F, Barrx Medical, Incorporated (2006) Summary page 2.
- K062441: Barrx Halo Coagulation System; Generator, Model 90-9000; Output Cable, Model 90-9010; Footswitch, Model 90-9020, Barrx Medical, Incorporated (2006) Summary page 2.
- K000241: Radiotherapeutics RF 3000 Radiofrequency Generator, Radiotherapeutics Corp. (2000) Summary page 2.

## Most influential descendants
- K141357: Barrx Flex Rfa Energy Generator (2014), 1 descendant of its own
- K160360: Barrx FLEX RFA Energy Generator (2016), 0 descendants of its own

## Recalls of this device
- Aug 3, 2012 · Class II · Z-2379-2012: Potential failure of HALO Energy Generator to enter "stand by" mode when initially powered on; and therefore can not be used for patient care.

## Indications for use
The HALOFLEX Energy Generator is indicated for use for the coagulation of soft tissue. The HALOFLEX Energy Generator 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.

Source page: https://510kreport.com/device/K092487
Methodology: https://510kreport.com/methodology