Clever Culture Systems AG: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Clever Culture Systems AG” (first 2019, latest 2019), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 140 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 |
|---|---|---|
| 2019 | 1 | 140 |
| 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 Clever Culture Systems AG took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PPU | Microbial Colony Image Assessment System | 2 | 1 |
Review panels
- Microbiology (2)
Most recent Clever Culture Systems AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183648 | APAS Independence with Urine Analysis Module | PPU | 2019-05-15 | 140 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150059 | De Novo | Microbial Colony Image Assessment System | 2016-10-06 |
Recalls
openFDA lists no recalls under a recalling firm named Clever Culture Systems AG.
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.
- Clever Culture Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clever Culture Systems AG?
FDA lists 1 510(k) clearance under the applicant name “Clever Culture Systems AG” (first 2019, latest 2019), 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 Clever Culture Systems AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clever Culture Systems AG is 140 days.
Which FDA product codes appear under Clever Culture Systems AG?
The most frequent FDA product codes under this applicant name are PPU (Microbial Colony Image Assessment System, 2).
Next steps
- See all 1 Clever Culture Systems AG clearances with predicates and recalls
- Run predicate analysis for product code PPU, Clever Culture Systems AG'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.