Diasol, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Diasol, Inc.” (first 1999, latest 2014), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 54 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 | 348 |
| 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 |
|---|---|---|---|
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 4 | 4 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FIE | Needle, Fistula | 1 | 1 |
Review panels
Most recent Diasol, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130511 | CITRISOL ACID CONCENTRATE | KPO | 2014-02-10 | 348 |
| K020231 | DIASOL-ADDITIVES | KPO | 2002-10-21 | 271 |
| K020230 | DIASOL-BICARB | KPO | 2002-04-23 | 90 |
| K011004 | NEEDLELOK HYPODERMIC NEEDLE PROTECTION | FMI | 2001-05-24 | 50 |
| K010958 | FISTULOK FISTULA NEEDLE PROTECTION | FMI | 2001-05-18 | 49 |
| K011003 | SAFESTING AND SAFESTING HUB | FPA | 2001-04-20 | 16 |
| K993187 | SHELLY PROTECTED AV FISTULA NEEDLE | FPA | 1999-11-05 | 43 |
| K992999 | DAISY PROTECTED SCALP VEIN SET | FPA | 1999-11-05 | 59 |
| K992653 | SHELLY PROTECTED AV FISTULA NEEDLE | FIE | 1999-10-27 | 82 |
| K993212 | DRYASOL ACID CONCENTRATE MIX | KPO | 1999-10-22 | 28 |
Recalls
8 product recalls in 3 recall events; 7 initiated in the last five years. Most recent: 2025-11-05.
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 Diasol, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Diasol, Inc.” (first 1999, latest 2014), across 4 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 Diasol, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diasol, Inc. is 54 days.
Which FDA product codes appear under Diasol, Inc.?
The most frequent FDA product codes under this applicant name are KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder), 4); FPA (Set, Administration, Intravascular, 3); FMI (Needle, Hypodermic, Single Lumen, 2).
Next steps
- See all 10 Diasol, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPO, Diasol, 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.