Scientific Intake: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Scientific Intake” (first 2017, latest 2017), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 28 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 |
|---|---|---|
| 2017 | 1 | 28 |
| 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 Scientific Intake took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 28 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ONY | Oral Removable Retainer For Weight Management | 2 | 1 |
Review panels
Most recent Scientific Intake 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171165 | SmartByte Device | ONY | 2017-05-18 | 28 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150033 | De Novo | Oral Removable Retainer For Weight Management | 2016-09-26 |
Recalls
openFDA lists no recalls under a recalling firm named Scientific Intake.
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.
- Scientific Pharmaceuticals, Inc. (73 510(k)s)
- Scientific Device Laboratory, Inc. (28 510(k)s)
- Scientific Sales Intl., Inc. (11 510(k)s)
- Scientific Distributors, Inc. (7 510(k)s)
- Scientific Device Manufacturer, LLC (6 510(k)s)
- Scientific Research (5 510(k)s)
- Scientific Imaging, Inc. (3 510(k)s)
- Scientific Specialties, Inc. (3 510(k)s)
- Scientific & General Pty. , Ltd. (2 510(k)s)
- Scientific Manufacturing Industries (2 510(k)s)
- Scientific Spinal , Ltd. (2 510(k)s)
- Scientific Standards, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scientific Intake?
FDA lists 1 510(k) clearance under the applicant name “Scientific Intake” (first 2017, latest 2017), plus 1 De Novo decision, across 1 product code 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 Scientific Intake?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scientific Intake is 28 days.
Which FDA product codes appear under Scientific Intake?
The most frequent FDA product codes under this applicant name are ONY (Oral Removable Retainer For Weight Management, 2).
Next steps
- See all 1 Scientific Intake clearances with predicates and recalls
- Run predicate analysis for product code ONY, Scientific Intake'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.