Misonix, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Misonix, Inc.” (first 1998, latest 2022), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 87 days. Since 2017 the median was 120 days, against 112 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 69 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 120 |
| 2020 | 0 | — |
| 2021 | 1 | 165 |
| 2022 | 1 | 90 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Misonix, Inc. took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | 10 | 10 |
| NRB | Wound Cleaner, Ultrasound | 2 | 2 |
| NTB | System, Ablation, Ultrasound And Accessories | 2 | 2 |
| GBX | Catheter, Irrigation | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| QPB | System, Suction, Lipoplasty For Removal | 1 | 1 |
Review panels
Most recent Misonix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221235 | neXus Ultrasonic Surgical Aspirator System | LFL | 2022-07-28 | 90 |
| K212060 | neXus Ultrasonic Surgical Aspirator System | LFL | 2021-12-13 | 165 |
| K190160 | neXus Ultrasonic Surgical Aspirator System | LFL | 2019-05-30 | 120 |
| K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | NRB | 2013-03-05 | 69 |
| K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | NRB | 2011-12-01 | 66 |
| K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | NTB | 2008-07-09 | 476 |
| K070313 | MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | 2007-05-11 | 99 |
| K062471 | ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF | LFL | 2006-10-26 | 63 |
| K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | NTB | 2006-01-26 | 540 |
| K052702 | MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY | GEI | 2005-11-21 | 54 |
7 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-08-13.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Misonix, LLC (1 510(k)s)
- Misonix, LLC, A Bioventus Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Misonix, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Misonix, Inc.” (first 1998, latest 2022), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Misonix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Misonix, Inc. is 87 days. Since 2017: 120 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Misonix, Inc.?
The most frequent FDA product codes under this applicant name are LFL (Instrument, Ultrasonic Surgical, 10); NRB (Wound Cleaner, Ultrasound, 2); NTB (System, Ablation, Ultrasound And Accessories, 2).
Next steps
- See all 17 Misonix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LFL, Misonix, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.