Cytori Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Cytori Therapeutics, Inc.” (first 2006, latest 2014), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 115 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 | 1 | 125 |
| 2013 | 0 | — |
| 2014 | 1 | 137 |
| 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 |
|---|---|---|---|
| MUU | System, Suction, Lipoplasty | 4 | 4 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| QPB | System, Suction, Lipoplasty For Removal | 1 | 1 |
Review panels
Most recent Cytori Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132815 | PUREGRAFT 50 SYSTEM | MUU | 2014-01-24 | 137 |
| K113255 | PUREGRAFT 850/PURE SYSTEM | MUU | 2012-03-07 | 125 |
| K092923 | CYTORI PUREGRAFT 250/PURE SYSTEM | MUU | 2010-01-06 | 105 |
| K072587 | CYTORI AFT SYSTEM | MUU | 2007-12-10 | 87 |
| K063235 | CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT | QPB | 2007-01-24 | 91 |
| K060482 | CYTORI CELUTION CELL CONCENTRATION DEVICE | CAC | 2006-09-28 | 217 |
Recalls
openFDA lists no recalls under a recalling firm named Cytori Therapeutics, 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.
Device clinical trials
An industry sponsor named Cytori Therapeutics, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07360808: Safety and Efficacy of Adipose-Derived Regenerative Cells (ADRCs) for Improving Hand Dysfunction in Systemic Sclerosis (Recruiting, started 2025-12-31)
- NCT02362386: Feasibility of Obtaining ADRCs From Discarded Thermal Burn Eschar Tissue Using Investigational Celution® System (Completed, started 2015-06)
- NCT02396238: Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR) (Completed, started 2015-05-15)
- NCT02326961: Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee (Completed, started 2015-01)
- NCT02052427: Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II) (Completed, started 2014-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cytori Therapeutics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Cytori Therapeutics, Inc.” (first 2006, latest 2014), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cytori Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cytori Therapeutics, Inc. is 115 days.
Which FDA product codes appear under Cytori Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are MUU (System, Suction, Lipoplasty, 4); CAC (Apparatus, Autotransfusion, 1); QPB (System, Suction, Lipoplasty For Removal, 1).
Next steps
- See all 6 Cytori Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUU, Cytori Therapeutics, 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.