Cleared Special

K231169 - STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231169 · Plasmapp Co,., Ltd. · General Hospital

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Optimized for regulatory review, auditing and printing

May 2023

Decision

30d

Days

Class 2

Risk

K231169 is an FDA 510(k) clearance for the STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERL.... 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 May 25, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Plasmapp Co,., Ltd. devices

Submission Details

510(k) Number	K231169 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 25, 2023
Decision Date	May 25, 2023
Days to Decision	30 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

98d faster than avg

Panel avg: 128d · This submission: 30d

Pathway characteristics

Modification to existing cleared device.

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.

Regulatory Consultant

CardioMed Device Consultants, LLC

Candace Cederman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.