# Plasmapp Co,., Ltd.

- Location (FDA's records): Daejeon, KR
- FDA decisions: 8 (2021–2023): 8 510(k) clearances
- Product codes: MLR (4), FRC (2), FRG (2)
- 510(k) review time since 2016: median 222 days, against 222 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 12 (9 its own); citations of its devices by later devices: 9 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Terragene S.A.: 1 (https://510kreport.com/company/terragene)
- Sigma Medical Supplies Corp.: 1 (https://510kreport.com/company/sigma-medical-supplies)
- Sterilucent, Inc.: 1 (https://510kreport.com/company/sterilucent)

## Its most-cited devices
- K212193: Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (2021), cited by 3
- K212198: Tyvek (R) Roll with CI for STERLINKTM Sterilizer (2021), cited by 3
- K212200: STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (2021), cited by 3

## Recent decisions
- 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) (May 25, 2023)
- K223023: Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (May 9, 2023)
- K223015: STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (May 9, 2023)
- K223025: Tyvek Roll with CI for STERLINK Sterilizer (May 9, 2023)
- 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) (Apr 14, 2023)
- K212193: Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (Oct 22, 2021)
- K212198: Tyvek (R) Roll with CI for STERLINKTM Sterilizer (Oct 22, 2021)
- K212200: STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (Oct 22, 2021)

Source page: https://510kreport.com/company/plasmapp