Lexion Medical, LLC: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Lexion Medical, LLC” (first 2007, latest 2019), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 66 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 | 1 | 138 |
| 2013 | 2 | 52 |
| 2014 | 1 | 30 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 242 |
| 2018 | 0 | — |
| 2019 | 1 | 57 |
| 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 Lexion Medical, LLC took a median 150 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 | 12 | 12 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 1 | 1 |
Review panels
Most recent Lexion Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191780 | AP50/30 Insufflator with Insuflow Port | HIF | 2019-08-28 | 57 |
| K170799 | AP 50/30 Insufflator with Insuflow Port | HIF | 2017-11-14 | 242 |
| K140263 | INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT | HIF | 2014-03-05 | 30 |
| K132203 | PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA | HIF | 2013-09-20 | 66 |
| K132204 | INSUFLOW SYNERGY XL PORT | HIF | 2013-08-22 | 37 |
| K120640 | INSUFLOW SYNERGY PORT | HIF | 2012-07-18 | 138 |
| K112357 | VESSEL GUARDIAN | HIF | 2011-11-10 | 86 |
| K102136 | VESSEL GUARDIAN | HIF | 2010-09-27 | 60 |
| K101320 | VASOVAPOR | HIF | 2010-06-24 | 44 |
| K091366 | INSUFLOW DEWHEART | HIF | 2009-09-03 | 118 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lexion Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lexion Medical, LLC?
FDA lists 13 510(k) clearances under the applicant name “Lexion Medical, LLC” (first 2007, latest 2019), 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 Lexion Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lexion Medical, LLC is 66 days.
Which FDA product codes appear under Lexion Medical, LLC?
The most frequent FDA product codes under this applicant name are HIF (Insufflator, Laparoscopic, 12); FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope, 1).
Next steps
- See all 13 Lexion Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code HIF, Lexion Medical, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.