Lysonix, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Lysonix, Inc.” (first 1997, latest 1998), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 83 days. 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QPB | System, Suction, Lipoplasty For Removal | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Lysonix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980771 | LYSONIX SUCTION LIPOPLASTY SYSTEM | QPB | 1998-07-13 | 136 |
| K980763 | LYSONIX LIPOPLASTY ACCESS PORT | QPB | 1998-05-28 | 90 |
| K980454 | LYSONIX ASPIRATION PUMP | BTA | 1998-03-18 | 41 |
| K974233 | LYSONIX IRRIGATION SYSTEM | GBX | 1998-02-03 | 83 |
| K972958 | LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS | GCJ | 1997-09-19 | 39 |
Recalls
openFDA lists no recalls under a recalling firm named Lysonix, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lysonix, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Lysonix, Inc.” (first 1997, latest 1998), across 4 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 Lysonix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lysonix, Inc. is 83 days.
Which FDA product codes appear under Lysonix, Inc.?
The most frequent FDA product codes under this applicant name are QPB (System, Suction, Lipoplasty For Removal, 2); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1); GBX (Catheter, Irrigation, 1).
Next steps
- See all 5 Lysonix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QPB, Lysonix, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.