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)
FDA 510(k) K220345 · Plasmapp Co,., Ltd.
510(k) numberK220345
Submission
- Device name
- 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)
- Applicant
- Plasmapp Co,., Ltd.
Daejeon, KR - Received
- February 7, 2022
- Decision date
- April 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLR – Sterilizer, Chemical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6860
- Specialty
- General Hospital
Other 510(k)s with product code MLR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104)MLR · Traditional | Advanced Sterilization Products, Inc. | 04/15/2026SE |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104)MLR · Traditional | Advanced Sterilization Products, Inc. | 04/14/2025SE |
| K231893 | LOWTEM Crystal 120MLR · Traditional | Lowtem Co., Ltd. | 09/18/2024SE |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104)…MLR · Traditional | Advanced Sterilization Products | 07/05/2024SE |
| K233762 | SteroScope® Sterilization Technology SystemMLR · Traditional | Ideate Medical, Inc. | 06/27/2024SE |
| K233065 | V-PRO maX 2 Low Temperature Sterilization SystemMLR · Special | Steris | 10/20/2023SE |
| K223476 | V-PRO maX 2 Low Temperature Sterilization SystemMLR · Traditional | STERIS Corporation | 08/07/2023SE |
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…MLR · Special | Plasmapp Co,., Ltd. | 05/25/2023SE |
| K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassetteMLR · Traditional | Plasmapp Co,., Ltd. | 05/09/2023SE |
| K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature…MLR · Special | Steris | 09/09/2022SE |
More from Steris
| 510(k) | Device | Decision |
|---|---|---|
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…MLR · Special | 05/25/2023SE |
| K223025 | Tyvek Roll with CI for STERLINK SterilizerFRG · Traditional | 05/09/2023SE |
| K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD…FRC · Traditional | 05/09/2023SE |
| K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassetteMLR · Traditional | 05/09/2023SE |
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM CassetteMLR · Traditional | 10/22/2021SE |
| K212198 | Tyvek(R) Roll with CI for STERLINKTM SterilizerFRG · Traditional | 10/22/2021SE |
| K212193 | Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD…FRC · Traditional | 10/22/2021SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K220345) received a 510(k) decision of Substantially Equivalent on April 14, 2023, 431 days after the submission was received.
What is the product code of K220345?
The FDA product code is MLR – Sterilizer, Chemical, a Class II (moderate risk) device regulated under 21 CFR 880.6860.