Cleared Traditional

K220345 - STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer (FDA 510(k) Clearance)

Also includes:

Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220345 · Plasmapp Co,., Ltd. · General Hospital

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Apr 2023

Decision

431d

Days

Class 2

Risk

K220345 is an FDA 510(k) clearance for the STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for .... Classified as Sterilizer, Chemical (product code MLR), Class II - Special Controls.

Submitted by Plasmapp Co,., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on April 14, 2023 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Plasmapp Co,., Ltd. devices

Submission Details

510(k) Number	K220345 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 07, 2022
Decision Date	April 14, 2023
Days to Decision	431 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

303d slower than avg

Panel avg: 128d · This submission: 431d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	MLR Sterilizer, Chemical
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 880.6860

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.