# K091038: AS 1000 Ultrasound Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Arobella Medical, LLC
- Decided: Jun 19, 2009 after 67 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: 5 generations back to K945062 (1995). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050129: Celleration Mist Therapy System 5.1, Celleration, Inc. (2005) Summary page 1.
- K062544: AR1000 Ultrasonic Wound Therapy System, Arobella Medical, LLC (2007) Summary page 1.
- K060782: Versajet Hydrosurgery System and Handpiece, Smith & Nephew Wound Management (2006) Summary page 1.
- (no number) DeRoyal JetOx-ND: named in the summary without a submission number
- (no number) DeRoyal JetOx HDC: named in the summary without a submission number

## Indications for use
Promotes wound healing through lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and maintenance debridement for the removal of debris, exudates, fragments, bacteria and other matter.

Source page: https://510kreport.com/device/K091038
Methodology: https://510kreport.com/methodology