Advanced Cooling Therapy, Inc. D/B/A Attune Medical: FDA clearances and approvals
Advanced Cooling Therapy, Inc. D/B/A Attune Medical has 2 FDA 510(k) clearances (first 2018, latest 2018), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 43 days. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 43 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Advanced Cooling Therapy, Inc. D/B/A Attune Medical's cleared 510(k)s took a median 43 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 86 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PLA | Esophageal Thermal Regulation And Gastric Suctioning Device | 2 | 2 |
| QXV | Temperature Regulation Device For Esophageal Protection During Cardiac Ablation | 1 | 0 |
Review panels
- Cardiovascular (3)
Most recent Advanced Cooling Therapy, Inc. D/B/A Attune Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180742 | EnsoETM | PLA | 2018-05-17 | 56 |
| K180244 | EnsoETM | PLA | 2018-02-28 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230021 | De Novo | Temperature Regulation Device For Esophageal Protection During Cardiac Ablation | 2023-09-13 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Cooling Therapy, Inc. D/B/A Attune Medical.
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.
Device clinical trials
Advanced Cooling Therapy, Inc. D/B/A Attune Medical is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04087122: Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures (Completed, started 2019-09-30)
- NCT04063761: Evaluating Active Esophageal Cooling During Cardiac Ablation Procedures (Completed, started 2019-06-20)
- NCT02420639: Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device (Completed, started 2015-08)
Frequently asked questions
How many FDA 510(k) clearances does Advanced Cooling Therapy, Inc. D/B/A Attune Medical have?
Advanced Cooling Therapy, Inc. D/B/A Attune Medical has 2 FDA 510(k) clearances (first 2018, latest 2018), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Advanced Cooling Therapy, Inc. D/B/A Attune Medical's 510(k)s?
The median time from FDA receipt to decision across Advanced Cooling Therapy, Inc. D/B/A Attune Medical's cleared 510(k)s is 43 days.
What devices does Advanced Cooling Therapy, Inc. D/B/A Attune Medical make?
Its most frequent FDA product codes are PLA (Esophageal Thermal Regulation And Gastric Suctioning Device, 2); QXV (Temperature Regulation Device For Esophageal Protection During Cardiac Ablation, 1).
Has Advanced Cooling Therapy, Inc. D/B/A Attune Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Cooling Therapy, Inc. D/B/A Attune Medical. Related entities may recall under other names.
Next steps
- See all 2 Advanced Cooling Therapy, Inc. D/B/A Attune Medical clearances with predicates and recalls
- Run predicate analysis for product code PLA, Advanced Cooling Therapy, Inc. D/B/A Attune Medical'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.