# K123980: Sonicone Plus Ultrasound Wound Care System and Accessories

- Pathway: 510(k) (Special)
- Applicant: Misonix, Inc.
- Decided: Mar 5, 2013 after 69 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). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories, Misonix, Inc. (2011)
- K070313: Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System, Misonix, Inc. (2007) Summary page 1.
- K050322: Microtek Equipment Drapes, Microtek Medical, Inc. (2005) Summary page 1.

## 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, bum wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

Source page: https://510kreport.com/device/K123980
Methodology: https://510kreport.com/methodology