Cleared Traditional

K223015 - STERLINK FPS-15s Plus sterilizer with S...

K223015 is an FDA 510(k) clearance for STERLINK FPS-15s Plus sterilizer with S..., manufactured by Plasmapp Co,., Ltd.. The device is a Class 2 General Hospital device with product code MLR cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K223015 · Plasmapp Co,., Ltd. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K223015

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.

MLR Device Classification - Class 2, Special Controls

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 42
Devices cleared under the same product code (MLR) and FDA review panel - the closest regulatory comparables to K223015.
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