Advanced Cooling Therapy, LLC: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Advanced Cooling Therapy, LLC” (first 2016, latest 2017), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 113 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 |
|---|---|---|
| 2016 | 1 | 140 |
| 2017 | 1 | 86 |
| 2018 | 0 | — |
| 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, 510(k)s cleared under the name Advanced Cooling Therapy, LLC took a median 86 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 | 3 | 2 |
Review panels
- Cardiovascular (3)
Most recent Advanced Cooling Therapy, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170009 | Esophageal Cooling Device | PLA | 2017-03-30 | 86 |
| K152450 | Esophageal Cooling Device | PLA | 2016-01-15 | 140 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN140018 | De Novo | Esophageal Thermal Regulation And Gastric Suctioning Device | 2015-06-23 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Cooling Therapy, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Medical Solutions, Ltd. (22 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Cooling Therapy, LLC?
FDA lists 2 510(k) clearances under the applicant name “Advanced Cooling Therapy, LLC” (first 2016, latest 2017), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Advanced Cooling Therapy, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Cooling Therapy, LLC is 113 days.
Which FDA product codes appear under Advanced Cooling Therapy, LLC?
The most frequent FDA product codes under this applicant name are PLA (Esophageal Thermal Regulation And Gastric Suctioning Device, 3).
Next steps
- See all 2 Advanced Cooling Therapy, LLC clearances with predicates and recalls
- Run predicate analysis for product code PLA, Advanced Cooling Therapy, LLC'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.