Home / 510(k) Clearances / K220345

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

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)
  • K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD (May 9, 2023)
  • K223025 — Tyvek Roll with CI for STERLINK Sterilizer (May 9, 2023)
  • K212198 — Tyvek(R) Roll with CI for STERLINKTM Sterilizer (October 22, 2021)
  • K212200 — STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette (October 22, 2021)
  • K212193 — Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD (October 22, 2021)

Other clearances for product code MLR

  • 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)
  • K220404 — STERRAD NX with ALLClear Technology (May 16, 2022)