Scientific Device Manufacturer, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Scientific Device Manufacturer, LLC” (first 1995, latest 1997), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 191 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 | 1 |
| KXO | Monitor, Pressure, Intrauterine | 1 | 1 |
Review panels
Most recent Scientific Device Manufacturer, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960764 | SAFE-CATH | FOZ | 1997-04-24 | 423 |
| K960431 | PRESSURE STOPCOCK/MANIFOLD | FPA | 1996-10-29 | 272 |
| K961290 | IUP - TIP TRANS, IUP - PROXI TRANS | KXO | 1996-10-15 | 194 |
| K960430 | CONTROL SYRINGE | DXT | 1996-08-06 | 188 |
| K960917 | PERCUGLIDE | DRE | 1996-07-02 | 118 |
| K952579 | TOCO TRANSDUCER | HFM | 1995-08-04 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Scientific Device Manufacturer, LLC.
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 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)
- Scientific Technology , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Scientific Device Manufacturer, LLC?
FDA lists 6 510(k) clearances under the applicant name “Scientific Device Manufacturer, LLC” (first 1995, latest 1997), across 6 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 Scientific Device Manufacturer, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scientific Device Manufacturer, LLC is 191 days.
Which FDA product codes appear under Scientific Device Manufacturer, LLC?
The most frequent FDA product codes under this applicant name are DRE (Dilator, Vessel, For Percutaneous Catheterization, 1); DXT (Injector And Syringe, Angiographic, 1); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Next steps
- See all 6 Scientific Device Manufacturer, LLC clearances with predicates and recalls
- Run predicate analysis for product code DRE, Scientific Device Manufacturer, LLC'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.