FDA applicant
Plasmapp Co,., Ltd.
FDA records 8 decisions for Plasmapp Co,., Ltd. (Daejeon, KR) from 2021 to 2023: 8 510(k) clearances. Most are in product codes MLR (Sterilizer, Chemical) and FRC (Indicator, Biological Sterilization Process). Since 2016 its 510(k)s took a median of 222 days from receipt to decision, against 222 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 9 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Plasmapp Co,., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Plasmapp Co,., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report