# K131096: AR1000 Series Ultrasonic Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Arobella Medical, LLC
- Decided: May 16, 2014 after 393 days
- Product code: NRB (Wound Cleaner, Ultrasound)
- Device class: 2
- Regulation: 21 CFR 878.4410
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945062 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062544: AR1000 Ultrasonic Wound Therapy System, Arobella Medical, LLC (2007) Summary page 1.
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories, Misonix, Inc. (2011) Summary page 11.
- K122246: Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12, Celleration, Inc. (2012) Summary page 11.
- K072904: Sonoca 180/195 Wound Care System, Soering GmbH (2008) Summary page 1.
- K002906: Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07, Ethicon Endo-Surgery, Inc. (2000) Summary page 11.

## Indications for use
The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing via: * Selective and non-selective dissection and fragmentation of soft and or hard tissue; * Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, bums) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and esehar, fibrin, tissue exudates, bacteria and other matter. Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DM). The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing via: * Site cleansing irrigation and lavage of wound tissue (acute and chronic wounds, bums, diseased or necrotic tissue); * Contact and or non-contact maintenance debridement for the removal of debris, exudates, fragments, bacteria, slough, fibrin, excised or fragmented tissue, and other matter. IRRIGATION (LAVAGE) FLUID * Irrigation fluid may be sterile de-ionized water, sterile saline solution, other approved wound therapy or debridemnent solution. Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DMV). The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing by: Preparing the wound bed for graft or other subsequent procedures using contact and or non-contact techniques to achieve wound debridement. Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DMV).

Source page: https://510kreport.com/device/K131096
Methodology: https://510kreport.com/methodology