Nexus Medical, LLC: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Nexus Medical, LLC” (first 2003, latest 2015), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 132 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 | 153 |
| 2013 | 2 | 108 |
| 2014 | 1 | 203 |
| 2015 | 1 | 123 |
| 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 14 | 14 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
| LJH | System, Irrigation, Urological | 1 | 1 |
Review panels
Most recent Nexus Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142590 | All Safe Huber Safety Infusion Set | FPA | 2015-01-16 | 123 |
| K133351 | NEXUS NIS-6P LUER ACTIVATED DEVICE | FPA | 2014-05-22 | 203 |
| K130879 | NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS | FPA | 2013-07-09 | 102 |
| K130416 | NEXUS TKO-6P LUER ACTIVATED DEVICE | FPA | 2013-06-12 | 113 |
| K113398 | NEXUS TKO-6, LUER-ACTIVATED DEVICE | FPA | 2012-04-18 | 153 |
| K092382 | NEXUS PRESSURE RATED EXTENSION SETS | FPA | 2010-04-26 | 264 |
| K092930 | NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED | FPA | 2010-03-10 | 169 |
| K092527 | NEXUS INJECTION SITE, MODEL NIS-8 | FPA | 2010-02-04 | 170 |
| K081123 | NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS | FPA | 2008-11-14 | 207 |
| K080976 | NEXUS I.V. FLUID TRANSFER DEVICE | LHI | 2008-11-10 | 217 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nexus 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nexus Spine, LLC (19 510(k)s)
- Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. (3 510(k)s)
- Nexus Health Care Products , Ltd. (1 510(k)s)
- Nexus CMF, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nexus Medical, LLC?
FDA lists 16 510(k) clearances under the applicant name “Nexus Medical, LLC” (first 2003, latest 2015), across 3 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 Nexus Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nexus Medical, LLC is 132 days.
Which FDA product codes appear under Nexus Medical, LLC?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 14); LHI (Set, I.V. Fluid Transfer, 1); LJH (System, Irrigation, Urological, 1).
Next steps
- See all 16 Nexus Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code FPA, Nexus 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.