Direct Solutions: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Direct Solutions” (first 1995, latest 1996), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| GGM | Control, Hemoglobin | 2 | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 | 2 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 | 1 |
Review panels
- Clinical Chemistry (3)
- Hematology (2)
Most recent Direct Solutions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K963909 | HEMOCUE GLUCOLIN | JJX | 1996-11-08 | 39 |
| K964052 | HEMOCUE HEMOTROL | GGM | 1996-11-06 | 37 |
| K964053 | HEMOCUE GLUCOTROL | JJX | 1996-11-01 | 32 |
| K963908 | HEMOCUE HEMOLIN | GGM | 1996-10-16 | 16 |
| K955340 | EUROTROL GAS - ISE CONTROL | JJS | 1995-12-26 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Direct Solutions.
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.
- Direct Access Diagnostics (2 510(k)s)
- Direct Digital Imaging Technology (Beijing), Inc. (2 510(k)s)
- Direct Import Marketing Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Direct Solutions?
FDA lists 5 510(k) clearances under the applicant name “Direct Solutions” (first 1995, latest 1996), 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 Direct Solutions?
The median time from FDA receipt to decision across 510(k)s cleared under the name Direct Solutions is 36 days.
Which FDA product codes appear under Direct Solutions?
The most frequent FDA product codes under this applicant name are GGM (Control, Hemoglobin, 2); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 2); JJS (Controls For Blood-Gases, (Assayed And Unassayed), 1).
Next steps
- See all 5 Direct Solutions clearances with predicates and recalls
- Run predicate analysis for product code GGM, Direct Solutions'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.