Lucenxia Prescience AG: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Lucenxia Prescience AG” (first 2013, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 154 days. Since 2017 the median was 140 days, against 157 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 |
|---|---|---|
| 2013 | 3 | 115 |
| 2014 | 0 | — |
| 2015 | 2 | 154 |
| 2016 | 0 | — |
| 2017 | 2 | 114 |
| 2018 | 2 | 178 |
| 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 Lucenxia Prescience AG took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 9 | 9 |
Review panels
- General Hospital (9)
Most recent Lucenxia Prescience AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173304 | Finessis Intense Polyisoprene Surgical Glove | KGO | 2018-04-30 | 194 |
| K173386 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs | KGO | 2018-04-09 | 161 |
| K171987 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove | KGO | 2017-10-20 | 109 |
| K162852 | Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove | KGO | 2017-02-08 | 120 |
| K151607 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove | KGO | 2015-11-16 | 154 |
| K151605 | Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves | KGO | 2015-11-16 | 154 |
| K131751 | FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES | KGO | 2013-09-25 | 103 |
| K123629 | FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES | KGO | 2013-05-13 | 171 |
| K123628 | STERILE LATEX SURGICAL GLOVE | KGO | 2013-03-18 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Lucenxia Prescience AG.
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 Lucenxia Prescience AG?
FDA lists 9 510(k) clearances under the applicant name “Lucenxia Prescience AG” (first 2013, latest 2018), 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 Lucenxia Prescience AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lucenxia Prescience AG is 154 days. Since 2017: 140 days, versus 157 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lucenxia Prescience AG?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 9).
Next steps
- See all 9 Lucenxia Prescience AG clearances with predicates and recalls
- Run predicate analysis for product code KGO, Lucenxia Prescience AG'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.