# Misonix, Inc.

- Location (FDA's records): Farmingdale, NY
- FDA decisions: 18 (1998–2026): 18 510(k) clearances
- Names in FDA's records: Misonix, Inc. (17); Misonix, LLC (1)
- Product codes: LFL (11), NRB (2), NTB (2), QPB (1), GBX (1), GEI (1)
- 510(k) review time since 2016: median 105 days, against 101 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 32 (11 its own); citations of its devices by later devices: 23 (11 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Endocare, Inc.: 4 (https://510kreport.com/company/endocare)
- Microtek Medical, Inc.: 2 (https://510kreport.com/company/microtek-medical)
- Rita Medical Systems: 2 (https://510kreport.com/company/rita-medical-systems)
- Mentor Corp.: 1 (https://510kreport.com/company/mentor)
- Sound Surgical Technologies, LLC: 1 (https://510kreport.com/company/sound-surgical-technologies)
- Lysonix, Inc.: 1 (https://510kreport.com/company/lysonix)
- Arobella Medical, LLC: 1 (https://510kreport.com/company/arobella-medical)
- Boston Surgical Products, Inc.: 1 (https://510kreport.com/company/boston-surgical-products)

## Firms that cite its devices most
- Arobella Medical, LLC: 2 (https://510kreport.com/company/arobella-medical)
- Smtp Technology Co., Ltd.: 2 (https://510kreport.com/company/smtp-technology)
- Tenex Health, Inc.: 2 (https://510kreport.com/company/tenex-health)
- Andrew Technologies, LLC: 1 (https://510kreport.com/company/andrew-technologies)
- Misonix, LLC, A Bioventus Company: 1 (https://510kreport.com/company/misonix-a-bioventus)
- Soring GmbH Medizintechnik: 1 (https://510kreport.com/company/soring-medizintechnik)
- Soering GmbH: 1 (https://510kreport.com/company/soering)
- Acoustic Medsystems, Inc.: 1 (https://510kreport.com/company/acoustic-medsystems)

## Its most-cited devices
- K050776: Auss-6 Ultrasonic Surgical Aspirator System (2005), cited by 6
- K070313: Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System (2007), cited by 4
- K062471: Ultrasonic Surgical Aspirator System, Model FS 1000 RF (2006), cited by 3
- K041058: Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems (2004), cited by 2
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories (2011), cited by 2
- K012028: Alliger Ultrasonic Surgical System Model Auss-5 (2001), cited by 2

## Recent decisions
- K261448: neXus Ultrasonic Surgical Aspirator System (Jul 30, 2026)
- K221235: neXus Ultrasonic Surgical Aspirator System (Jul 28, 2022)
- K212060: neXus Ultrasonic Surgical Aspirator System (Dec 13, 2021)
- K190160: neXus Ultrasonic Surgical Aspirator System (May 30, 2019)
- K123980: Sonicone Plus Ultrasound Wound Care System and Accessories (Mar 5, 2013)
- K112782: Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories (Dec 1, 2011)
- K070779: Sonatherm 600I Ultrasonic Lesion Generating System (Jul 9, 2008)
- K070313: Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System (May 11, 2007)

Source page: https://510kreport.com/company/misonix