Smith River Biologicals: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Smith River Biologicals” (first 1984, latest 1993), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 24 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 |
|---|---|---|---|
| JSI | Culture Media, Selective And Differential | 2 | 2 |
| JSD | Culture Media, Selective Broth | 1 | 1 |
| JSE | Culture Media, Multiple Biochemical Test | 1 | 1 |
| JSF | Culture Media, Single Biochemical Test | 1 | 1 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
| JSH | Culture Media, Non-Selective And Differential | 1 | 1 |
| JSJ | Culture Media, Selective And Non-Differential | 1 | 1 |
| JSM | Culture Media, Non-Propagating Transport | 1 | 1 |
| JSN | Culture Media, Propagating Transport | 1 | 1 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 1 | 1 |
Plus 1 more product codes.
Review panels
- Microbiology (12)
Most recent Smith River Biologicals 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923892 | SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA | JSO | 1993-06-21 | 321 |
| K841209 | SELECTIVE AND DIFFERENTIAL | JSI | 1984-04-17 | 36 |
| K841207 | NON-SELECTIVE & NON-DIFFERENTIAL | JSI | 1984-04-17 | 36 |
| K841206 | NON-SELECTIVE & DIFFERENTIAL | JSH | 1984-04-17 | 36 |
| K841204 | MULTIPLE BIOCHEMICAL TEST | JSE | 1984-04-17 | 36 |
| K841211 | SELECTIVE BROTH | JSD | 1984-04-05 | 24 |
| K841208 | PROPAGATING TRANSPORT | JSN | 1984-04-05 | 24 |
| K841213 | ANTIMICROBIAL SUSCEPT-CULTURE MEDIA | JTZ | 1984-04-04 | 23 |
| K841212 | SINGLE BIOCHEMICAL TEST | JSF | 1984-04-04 | 23 |
| K841210 | SELECTIVE & NON-DIFFERENTIAL | JSJ | 1984-04-04 | 23 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Smith River Biologicals.
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.
- Smith & Nephew, Inc. (556 510(k)s)
- Smith & Nephew Richards, Inc. (87 510(k)s)
- Smith & Nephew United, Inc. (34 510(k)s)
- Smith & Nephew Medical Limited (30 510(k)s)
- Smith & Nephew Dyonics, Inc. (22 510(k)s)
- Smith & Nephew Endoscopy, Inc. (18 510(k)s)
- Smith and Nephew Donjoy, Inc. (15 510(k)s)
- Smith & Nephew Inc., Endoscopy Div. (10 510(k)s)
- Smith & Nephew, Inc., Orthopaedic Div. (10 510(k)s)
- Smith & Nephew Perry (10 510(k)s)
- Smith & Nephew, Mpl Division (9 510(k)s)
- Smith & Nephew Inc., Endoscopy Division (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smith River Biologicals?
FDA lists 12 510(k) clearances under the applicant name “Smith River Biologicals” (first 1984, latest 1993), across 11 product codes 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 Smith River Biologicals?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith River Biologicals is 24 days.
Which FDA product codes appear under Smith River Biologicals?
The most frequent FDA product codes under this applicant name are JSI (Culture Media, Selective And Differential, 2); JSD (Culture Media, Selective Broth, 1); JSE (Culture Media, Multiple Biochemical Test, 1).
Next steps
- See all 12 Smith River Biologicals clearances with predicates and recalls
- Run predicate analysis for product code JSI, Smith River Biologicals'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.