Arizant Healthcare, Inc.: FDA clearances and approvals
Arizant Healthcare, Inc. has 6 FDA 510(k) clearances (first 2004, latest 2012), across 3 product codes in 2 review panels. Median 510(k) review time: 65 days. openFDA lists 2 product recalls by a recalling firm named Arizant Healthcare, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 110 |
| 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 |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 3 | 3 |
| LGZ | Warmer, Thermal, Infusion Fluid | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Cardiovascular (3)
- General Hospital (3)
Most recent Arizant Healthcare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120412 | 3M SPOTON TEMPERATURE MONITORING SYSTEM | FLL | 2012-05-30 | 110 |
| K082217 | RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM | LGZ | 2008-10-06 | 61 |
| K060939 | RANGER IRRIGATION FLUID WARMING SYSTEM | LGZ | 2006-06-26 | 81 |
| K060865 | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 | DWJ | 2006-04-24 | 25 |
| K053645 | MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS | DWJ | 2006-03-09 | 69 |
| K041686 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM | DWJ | 2004-06-30 | 8 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-06-26.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Arizant Healthcare, Inc. have?
Arizant Healthcare, Inc. has 6 FDA 510(k) clearances (first 2004, latest 2012), across 3 product codes in 2 review panels.
How long does FDA take to clear Arizant Healthcare, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Arizant Healthcare, Inc.'s cleared 510(k)s is 65 days.
What devices does Arizant Healthcare, Inc. make?
Its most frequent FDA product codes are DWJ (System, Thermal Regulating, 3); LGZ (Warmer, Thermal, Infusion Fluid, 2); FLL (Continuous Measurement Thermometer, 1).
Has Arizant Healthcare, Inc. had device recalls?
openFDA lists 2 product recalls in 1 recall event by a recalling firm whose name matches Arizant Healthcare, Inc; the most recent began 2007-06-26. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Arizant Healthcare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Arizant Healthcare, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.