Cleared Traditional

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (K223015) - FDA 510(k) Clearance

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

K223015 · Plasmapp Co,., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2023
Decision
222d
Days
Class 2
Risk

K223015 is an FDA 510(k) clearance for the STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette. 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 9, 2023 after a review of 222 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Plasmapp Co,., Ltd. devices

Submission Details

510(k) Number K223015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2022
Decision Date May 09, 2023
Days to Decision 222 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
93d slower than avg
Panel avg: 129d · This submission: 222d
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 K223015.
V-PRO maX 2 Low Temperature Sterilization System
K233065 · Steris · Oct 2023
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 mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer
K220345 · Plasmapp Co,., Ltd. · Apr 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