Lyphomed, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Lyphomed, Inc.” (first 1984, latest 1991), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 | 0 | — |
| 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 5 | 5 |
| LHI | Set, I.V. Fluid Transfer | 2 | 2 |
Plus 1 more product codes.
Review panels
- General Hospital (7)
Most recent Lyphomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910142 | SPARK KIT(R), MODIFICATION | FPA | 1991-05-14 | 120 |
| K864509 | SPARK-KIT(TM) | — | 1987-02-18 | 96 |
| K853019 | NITROGLYCERIN INFUSION SET | FPA | 1985-11-12 | 118 |
| K853086 | SECONDARY ADMINISTRATION SET | FPA | 1985-08-19 | 27 |
| K852882 | MAXIFILL TRANSFER SET | LHI | 1985-08-16 | 38 |
| K852881 | VENTED SECONDARY IV ADMINISTRATION SET | FPA | 1985-08-16 | 38 |
| K842678 | I.V. TRANSFER SPIKE | FPA | 1984-10-09 | 91 |
| K842345 | MAXIFILL TRANSFER SET | LHI | 1984-08-17 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Lyphomed, Inc..
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 Lyphomed, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Lyphomed, Inc.” (first 1984, latest 1991), across 3 product codes 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 Lyphomed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lyphomed, Inc. is 78 days.
Which FDA product codes appear under Lyphomed, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 5); LHI (Set, I.V. Fluid Transfer, 2).
Next steps
- See all 8 Lyphomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Lyphomed, 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, 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.