Acumedia Manufacturers, Inc.: FDA filings under this applicant name
FDA lists 177 510(k) clearances under the applicant name “Acumedia Manufacturers, Inc.” (first 1981, latest 1988), across 19 product codes in 3 review panels. Median 510(k) review time under this name: 14 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | 42 | 42 |
| JSI | Culture Media, Selective And Differential | 40 | 40 |
| JSJ | Culture Media, Selective And Non-Differential | 30 | 30 |
| JSH | Culture Media, Non-Selective And Differential | 21 | 21 |
| JSK | Supplement, Culture Media | 10 | 10 |
| JSA | Culture Media, Antibiotic Assay | 8 | 8 |
| JSC | Culture Media, General Nutrient Broth | 6 | 6 |
| JSM | Culture Media, Non-Propagating Transport | 3 | 3 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 | 3 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 2 | 2 |
Plus 9 more product codes.
Review panels
- Microbiology (172)
- Clinical Toxicology (2)
- Radiology (1)
Most recent Acumedia Manufacturers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881579 | AMIES TRANSPORT MEDIUM W/O CHARCOAL | JSN | 1988-04-18 | 7 |
| K881578 | STREPTOSEL | JSJ | 1988-04-18 | 7 |
| K881577 | MODIFIED SELECTIVE STREPTOCOCCUS AGAR | JSI | 1988-04-18 | 7 |
| K881576 | SELENITE BROTH | JSI | 1988-04-18 | 7 |
| K881575 | SELECTIVE STREPTOCOCCUS AGAR | JSI | 1988-04-18 | 7 |
| K881574 | W-L DIFFERENTIAL MEDIUM | JSJ | 1988-04-18 | 7 |
| K881573 | PHYTONE YEAST EXTRACT AGAR | JSJ | 1988-04-18 | 7 |
| K881572 | XL AGAR BASE | JSI | 1988-04-18 | 7 |
| K881571 | YM BROTH | JSJ | 1988-04-18 | 7 |
| K881570 | SABOURAUD MALTOSE AGAR | JSJ | 1988-04-18 | 7 |
167 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2018-08-02.
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 Acumedia Manufacturers, Inc.?
FDA lists 177 510(k) clearances under the applicant name “Acumedia Manufacturers, Inc.” (first 1981, latest 1988), across 19 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 Acumedia Manufacturers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acumedia Manufacturers, Inc. is 14 days.
Which FDA product codes appear under Acumedia Manufacturers, Inc.?
The most frequent FDA product codes under this applicant name are JSG (Culture Media, Non-Selective And Non-Differential, 42); JSI (Culture Media, Selective And Differential, 40); JSJ (Culture Media, Selective And Non-Differential, 30).
Next steps
- See all 177 Acumedia Manufacturers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSG, Acumedia Manufacturers, Inc.'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.