Palliare , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Palliare , Ltd.” (first 2020, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 172 days. Since 2017 the median was 172 days, against 131 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2020 | 2 | 122 |
| 2021 | 1 | 282 |
| 2022 | 0 | — |
| 2023 | 2 | 78 |
| 2024 | 1 | 227 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Palliare , Ltd. took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIF | Insufflator, Laparoscopic | 4 | 4 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 2 | 2 |
Review panels
Most recent Palliare , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232902 | EVA15 insufflator | HIF | 2024-05-02 | 227 |
| K230474 | EVA5 Insufflator | FCX | 2023-03-24 | 30 |
| K222901 | EVA15 insufflator | HIF | 2023-01-27 | 126 |
| K202922 | END 200 Endoscopic Tubeset | FCX | 2021-07-08 | 282 |
| K202799 | EVA15 | HIF | 2020-10-21 | 28 |
| K193520 | EVA 15 Insufflator | HIF | 2020-07-23 | 217 |
Recalls
openFDA lists no recalls under a recalling firm named Palliare , Ltd..
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 Palliare , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Palliare , Ltd.” (first 2020, latest 2024), 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 Palliare , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Palliare , Ltd. is 172 days. Since 2017: 172 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Palliare , Ltd.?
The most frequent FDA product codes under this applicant name are HIF (Insufflator, Laparoscopic, 4); FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope, 2).
Next steps
- See all 6 Palliare , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HIF, Palliare , Ltd.'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.