Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Plasmapp Co,., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
222 daysmedian FDA review time
431 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll | Plasmapp Co,., Ltd. | 2023-05-25 | 30 | 0 |
| K223015 | STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus casset | Plasmapp Co,., Ltd. | 2023-05-09 | 222 | 0 |
| K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incu | Plasmapp Co,., Ltd. | 2023-05-09 | 222 | 0 |
| K223025 | Tyvek Roll with CI for STERLINK Sterilizer | Plasmapp Co,., Ltd. | 2023-05-09 | 222 | 0 |
| K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek | Plasmapp Co,., Ltd. | 2023-04-14 | 431 | 0 |
| K212198 | Tyvek(R) Roll with CI for STERLINKTM Sterilizer | Plasmapp Co,., Ltd. | 2021-10-22 | 100 | 0 |
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | Plasmapp Co,., Ltd. | 2021-10-22 | 100 | 0 |
| K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incu | Plasmapp Co,., Ltd. | 2021-10-22 | 100 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda