510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220345Substantially Equivalent

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)

Plasmapp Co., Ltd., Daejeon, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220345 is the FDA 510(k) clearance record for 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), a class II device, cleared for Plasmapp Co,., Ltd. on under FDA product code MLR (Sterilizer, Chemical). FDA records list 8 510(k) clearances for Plasmapp Co,., Ltd., from to . As of , FDA records show no recalls naming K220345.

Clearance record

Decision date
Received
(431 days to decision)
Product code
MLR Sterilizer, Chemical
Regulation
21 CFR 880.6860
Device class
Class II
Review panel
General Hospital
Applicant
Plasmapp Co,., Ltd. Bvc-111, 125, Gwahak-Ro, Yuseong-Gu, Daejeon, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MLR

Trailing 12 months
1 clearance under product code MLR in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MLR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260