Medivance, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Medivance, Inc.” (first 2000, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 87 days. Since 2017 the median was 120 days, against 189 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 | 1 | 122 |
| 2013 | 0 | — |
| 2014 | 1 | 87 |
| 2015 | 0 | — |
| 2016 | 1 | 85 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 29 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 126 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medivance, 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 189 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 10 | 10 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| NCX | System, Hypothermia, Intravenous, Cooling | 1 | 1 |
Review panels
- Cardiovascular (10)
- General Hospital (1)
- Neurology (1)
Most recent Medivance, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251974 | Arctic Sun Temperature Management System (Model 5000) | DWJ | 2025-10-24 | 120 |
| K243942 | Arctic Sun Stat Temperature Management System | DWJ | 2025-04-30 | 131 |
| K200225 | Arctic Sun Stat Temperature Management System | DWJ | 2020-02-28 | 29 |
| K161602 | Arctic Sun Temperature Management System | DWJ | 2016-09-02 | 85 |
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad | DWJ | 2014-12-18 | 87 |
| K120849 | HYBRID ARCTICGEL PAD | DWJ | 2012-07-20 | 122 |
| K110956 | MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR | FLL | 2011-07-18 | 104 |
| K101092 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 | DWJ | 2010-07-16 | 87 |
| K080899 | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | NCX | 2008-08-07 | 129 |
| K071341 | MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 | DWJ | 2007-08-03 | 81 |
2 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 2 initiated in the last five years. Most recent: 2024-06-27.
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 Medivance, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00282373: Induction of Mild Hypothermia in Resuscitated Cardiac Arrest Patients (Completed, started 2004-11)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medivance, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Medivance, Inc.” (first 2000, latest 2025), across 3 product codes in 3 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 Medivance, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medivance, Inc. is 87 days. Since 2017: 120 days, versus 189 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medivance, Inc.?
The most frequent FDA product codes under this applicant name are DWJ (System, Thermal Regulating, 10); FLL (Continuous Measurement Thermometer, 1); NCX (System, Hypothermia, Intravenous, Cooling, 1).
Next steps
- See all 12 Medivance, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Medivance, 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.