Cleared Traditional

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

Also marketed or referenced as:
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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
302d slower than avg
Panel avg: 129d · 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.

Regulatory Peers - MLR Sterilizer, Chemical

All 30
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K220345.
V-PRO maX 2 Low Temperature Sterilization System
K223476 · STERIS Corporation · Aug 2023
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)
K231169 · Plasmapp Co,., Ltd. · May 2023
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
K223015 · Plasmapp Co,., Ltd. · May 2023
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System
K222093 · Steris · Sep 2022
STERRAD NX with ALLClear Technology
K220404 · Advanced Sterilization Products, Inc. · May 2022
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
K212200 · Plasmapp Co,., Ltd. · Oct 2021