# K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Misonix, Inc.
- Decided: Dec 1, 2011 after 66 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). 24 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 27 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.
- K050776: Auss-6 Ultrasonic Surgical Aspirator System, Misonix, Inc. (2005) Summary page 1.
- K050322: Microtek Equipment Drapes, Microtek Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridernent and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of anl ultrasonic aspirator with sharp debridement.

Source page: https://510kreport.com/device/K112782
Methodology: https://510kreport.com/methodology