# K062544: AR1000 Ultrasonic Wound Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Arobella Medical, LLC
- Decided: Jan 3, 2007 after 126 days
- Product code: LFL (Instrument, Ultrasonic Surgical)
- Device class: U
- 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: 4 generations back to K945062 (1995). 20 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050776: Auss-6 Ultrasonic Surgical Aspirator System, Misonix, Inc. (2005) Summary page 1.
- K012753: Soring GMBH Sonoca 180/190, Soring GmbH Medizintechnik (2001) Summary page 1.
- K060782: Versajet Hydrosurgery System and Handpiece, Smith & Nephew Wound Management (2006) Summary page 1.
- K050129: Celleration Mist Therapy System 5.1, Celleration, Inc. (2005) Summary page 1.

## Most influential descendants
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories (2011), 2 descendants of its own
- K072904: Sonoca 180/195 Wound Care System (2008), 1 descendant of its own
- K131096: AR1000 Series Ultrasonic Wound Therapy System (2014), 0 descendants of its own
- K123980: Sonicone Plus Ultrasound Wound Care System and Accessories (2013), 0 descendants of its own
- K091038: AS 1000 Ultrasound Wound Therapy System (2009), 0 descendants of its own

## Recalls of this device
- Nov 5, 2012 · Class II · Z-0534-2013: This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component o

## Indications for use
Selective dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter.

Source page: https://510kreport.com/device/K062544
Methodology: https://510kreport.com/methodology