Aalto Scientific, Ltd.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Aalto Scientific, Ltd.” (first 1982, latest 2017), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 66 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 | 4 | 212 |
| 2013 | 3 | 40 |
| 2014 | 2 | 34 |
| 2015 | 2 | 34 |
| 2016 | 1 | 33 |
| 2017 | 1 | 78 |
| 2018 | 0 | — |
| 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 Aalto Scientific, Ltd. took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 19 | 19 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 9 | 9 |
| GGN | Plasma, Coagulation Control | 1 | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 | 1 |
| GLK | Control, Hematocrit | 1 | 1 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 1 | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 | 1 |
| JPK | Mixture, Hematology Quality Control | 1 | 1 |
| MJX | Kit, Serological, Positive Control | 1 | 1 |
Review panels
- Clinical Chemistry (30)
- Hematology (4)
- Microbiology (1)
Most recent Aalto Scientific, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163629 | Audit MicroControls Linearity FD Tumor Markers II | JJY | 2017-03-10 | 78 |
| K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | JJX | 2016-08-10 | 33 |
| K143571 | Audit MicroControls Linearity LQ Cystatin-C | JJX | 2015-01-23 | 37 |
| K143573 | Audit MicroControls Linearity FD Tumor Markers II | JJY | 2015-01-16 | 30 |
| K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity | JJX | 2014-11-21 | 31 |
| K142978 | Audit MicroControls Linearity LQ Special Diabetes | JJY | 2014-11-20 | 36 |
| K130762 | AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET | JJY | 2013-04-29 | 40 |
| K130764 | AUDIT MICROCV VITAMIN D LINEARITY SET | JJX | 2013-04-26 | 37 |
| K130157 | AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET | JJX | 2013-03-19 | 55 |
| K112742 | AUDIT MICROLQ SPINAL FLUID CONTROL | JJY | 2012-06-15 | 268 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aalto Scientific, Ltd..
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 Aalto Scientific, Ltd.?
FDA lists 35 510(k) clearances under the applicant name “Aalto Scientific, Ltd.” (first 1982, latest 2017), across 9 product codes in 3 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 Aalto Scientific, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aalto Scientific, Ltd. is 66 days.
Which FDA product codes appear under Aalto Scientific, Ltd.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 19); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 9); GGN (Plasma, Coagulation Control, 1).
Next steps
- See all 35 Aalto Scientific, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Aalto Scientific, Ltd.'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.