Plasmapp Co,., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Plasmapp Co,., Ltd.” (first 2021, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 161 days. Since 2017 the median was 161 days, against 136 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2021 | 3 | 100 |
| 2022 | 0 | — |
| 2023 | 5 | 222 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Plasmapp Co,., Ltd. took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MLR | Sterilizer, Chemical | 4 | 4 |
| FRC | Indicator, Biological Sterilization Process | 2 | 2 |
| FRG | Wrap, Sterilization | 2 | 2 |
Review panels
- General Hospital (8)
Most recent Plasmapp Co,., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | MLR | 2023-05-25 | 30 |
| K223025 | Tyvek Roll with CI for STERLINK Sterilizer | FRG | 2023-05-09 | 222 |
| K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | FRC | 2023-05-09 | 222 |
| K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette | MLR | 2023-05-09 | 222 |
| K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | MLR | 2023-04-14 | 431 |
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | MLR | 2021-10-22 | 100 |
| K212198 | Tyvek(R) Roll with CI for STERLINKTM Sterilizer | FRG | 2021-10-22 | 100 |
| K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | FRC | 2021-10-22 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Plasmapp Co,., Ltd..
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 Plasmapp Co,., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Plasmapp Co,., Ltd.” (first 2021, latest 2023), across 3 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 Plasmapp Co,., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Plasmapp Co,., Ltd. is 161 days. Since 2017: 161 days, versus 136 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Plasmapp Co,., Ltd.?
The most frequent FDA product codes under this applicant name are MLR (Sterilizer, Chemical, 4); FRC (Indicator, Biological Sterilization Process, 2); FRG (Wrap, Sterilization, 2).
Next steps
- See all 8 Plasmapp Co,., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MLR, Plasmapp Co,., Ltd.'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.