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510(k) 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) by Plasmapp Co,., Ltd. — Product Code MLR

K220345 is an FDA 510(k) premarket notification submitted by Plasmapp Co,., Ltd. for the device "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)". The FDA issued a decision of Substantially Equivalent on April 14, 2023. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Plasmapp Co,., Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2023
Date Received
February 7, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by Plasmapp Co,., Ltd.

  • K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK (May 25, 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)
  • K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD (May 9, 2023)
  • K212200 — STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (October 22, 2021)
  • K212198 — Tyvek(R) Roll with CI for STERLINKTM Sterilizer (October 22, 2021)
  • K212193 — Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD (October 22, 2021)

Other clearances for product code MLR

  • K252843 — STERRAD 100NX Sterilization System with ALLClear Technology (10104) (April 15, 2026)
  • K250802 — STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (April 14, 2025)
  • K231893 — LOWTEM Crystal 120 (September 18, 2024)
  • K234082 — STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); (July 5, 2024)
  • K233762 — SteroScope® Sterilization Technology System (June 27, 2024)
  • K233065 — V-PRO maX 2 Low Temperature Sterilization System (October 20, 2023)
  • K223476 — V-PRO maX 2 Low Temperature Sterilization System (August 7, 2023)
  • K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK (May 25, 2023)
  • K223015 — STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (May 9, 2023)
  • K222093 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Ster (September 9, 2022)

FDA data resources