Thermedx, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Thermedx, LLC” (first 2010, latest 2021), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 226 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 189 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 61 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 247 |
| 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 Thermedx, LLC took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIG | Insufflator, Hysteroscopic | 4 | 4 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Thermedx, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210628 | X-FLO Fluid Management System | HIG | 2021-11-04 | 247 |
| K172048 | FluidSmart | HIG | 2017-09-05 | 61 |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | HIG | 2014-06-20 | 189 |
| K102275 | THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 | GEI | 2011-03-25 | 226 |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | HIG | 2010-07-23 | 388 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-09-01.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Thermedx, LLC?
FDA lists 5 510(k) clearances under the applicant name “Thermedx, LLC” (first 2010, latest 2021), across 2 product codes in 2 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 Thermedx, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thermedx, LLC is 226 days.
Which FDA product codes appear under Thermedx, LLC?
The most frequent FDA product codes under this applicant name are HIG (Insufflator, Hysteroscopic, 4); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 5 Thermedx, LLC clearances with predicates and recalls
- Run predicate analysis for product code HIG, Thermedx, 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.