Xlumena, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under 2 spellings of the applicant name “Xlumena, Inc.” (first 2010, latest 2014), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 109 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 | 49 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PCU | Pancreatic Stent, Covered, Metallic, Removable | 2 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Xlumena, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140561 | AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) | PCU | 2014-04-23 | 49 |
| K093279 | NAVIX ACCESS DEVICE | GCJ | 2010-04-07 | 169 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130007 | De Novo | Pancreatic Stent, Covered, Metallic, Removable | 2013-12-18 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-04-17.
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.
Device clinical trials
An industry sponsor named Xlumena, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02146352: AXIOS Stent With Electrocautery Enhanced Delivery System (Completed, started 2014-06)
- NCT01419769: AXIOS Stent & Delivery System Study (Completed, started 2011-08)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Xlumena, Inc. (2)
- Xlumena (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Xlumena, Inc.?
FDA lists 2 510(k) clearances under 2 spellings of the applicant name “Xlumena, Inc.” (first 2010, latest 2014), plus 1 De Novo decision, 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 Xlumena, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xlumena, Inc. is 109 days.
Which FDA product codes appear under Xlumena, Inc.?
The most frequent FDA product codes under this applicant name are PCU (Pancreatic Stent, Covered, Metallic, Removable, 2); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 2 Xlumena, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PCU, Xlumena, Inc.'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.