Hardy Media: FDA filings under this applicant name
FDA lists 114 510(k) clearances under the applicant name “Hardy Media” (first 1981, latest 1988), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 49 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | 26 | 26 |
| JSF | Culture Media, Single Biochemical Test | 20 | 20 |
| JSI | Culture Media, Selective And Differential | 17 | 17 |
| JSG | Culture Media, Non-Selective And Non-Differential | 13 | 13 |
| KZI | Culture Media, Enriched | 9 | 9 |
| JSE | Culture Media, Multiple Biochemical Test | 7 | 7 |
| JSH | Culture Media, Non-Selective And Differential | 7 | 7 |
| JSC | Culture Media, General Nutrient Broth | 5 | 5 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 5 | 5 |
| JSM | Culture Media, Non-Propagating Transport | 2 | 2 |
Plus 2 more product codes.
Review panels
- Microbiology (114)
Most recent Hardy Media 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880134 | MIDDLEBROOK 7H11 AGAR | KZI | 1988-03-31 | 85 |
| K880133 | MIL MEDIUM | JSE | 1988-03-31 | 85 |
| K880131 | LOWENSTEIN-JENSEN, GRUFT | KZI | 1988-03-31 | 85 |
| K880126 | LAURYL TRYPTOSE BROTH | JSF | 1988-03-31 | 85 |
| K880125 | LOWENSTEIN-JENSEN, SELECTIVE | JSI | 1988-03-31 | 85 |
| K880124 | LOWENSTEIN-JENSEN, W/NACL | JSJ | 1988-03-31 | 85 |
| K880123 | LOWENSTEIN-JENSEN SLANT | JSJ | 1988-03-31 | 85 |
| K880122 | MIDDLEBROOK 7H9 BROTH | KZI | 1988-03-31 | 85 |
| K880121 | MOELLERS DECARBOXYLASE, BASE | JSH | 1988-03-31 | 85 |
| K880120 | MOELLERS DECARBOXYLASE, LYSINE | JSF | 1988-03-31 | 85 |
104 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hardy Media.
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.
- Hardy Diagnostics (110 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hardy Media?
FDA lists 114 510(k) clearances under the applicant name “Hardy Media” (first 1981, latest 1988), across 12 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 Hardy Media?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hardy Media is 49 days.
Which FDA product codes appear under Hardy Media?
The most frequent FDA product codes under this applicant name are JSJ (Culture Media, Selective And Non-Differential, 26); JSF (Culture Media, Single Biochemical Test, 20); JSI (Culture Media, Selective And Differential, 17).
Next steps
- See all 114 Hardy Media clearances with predicates and recalls
- Run predicate analysis for product code JSJ, Hardy Media'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.