Augustine Temperature Management, LLC: FDA clearances and approvals
Augustine Temperature Management, LLC has 5 FDA 510(k) clearances (first 2020, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time: 176 days. Since 2017 its median was 176 days, against 111 days for all cleared 510(k)s in the same product codes. openFDA lists 13 product recalls by a recalling firm named Augustine Temperature Management, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 73 |
| 2021 | 0 | — |
| 2022 | 2 | 252 |
| 2023 | 1 | 92 |
| 2024 | 1 | 233 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Augustine Temperature Management, LLC's cleared 510(k)s took a median 176 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DWJ | System, Thermal Regulating | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Augustine Temperature Management, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232627 | HotDog Warming Mattress + Return Electrode | DWJ | 2024-04-18 | 233 |
| K230866 | HotDog Warming Mattress + Return Electrode | DWJ | 2023-06-29 | 92 |
| K220941 | HotDog Temperature Management System | DWJ | 2022-09-23 | 176 |
| K210727 | HotDog Warming Mattress + Return Electrode | GEI | 2022-02-01 | 327 |
| K201779 | HotDog Temperature Management Controller | DWJ | 2020-09-11 | 73 |
Recalls
13 product recalls in 4 recall events; 13 initiated in the last five years. Most recent: 2024-12-16.
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 Augustine Temperature Management, LLC have?
Augustine Temperature Management, LLC has 5 FDA 510(k) clearances (first 2020, latest 2024), across 2 product codes in 2 review panels.
How long does FDA take to clear Augustine Temperature Management, LLC's 510(k)s?
The median time from FDA receipt to decision across Augustine Temperature Management, LLC's cleared 510(k)s is 176 days. Since 2017: 176 days, versus 111 days for all cleared 510(k)s in the same product codes.
What devices does Augustine Temperature Management, LLC make?
Its most frequent FDA product codes are DWJ (System, Thermal Regulating, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Has Augustine Temperature Management, LLC had device recalls?
openFDA lists 13 product recalls in 4 recall events by a recalling firm whose name matches Augustine Temperature Management, LLC; the most recent began 2024-12-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Augustine Temperature Management, LLC clearances with predicates and recalls
- Run predicate analysis for product code DWJ, Augustine Temperature Management, LLC'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.