Cleared Traditional

K082817 - PRIMUS STEAM STERILIZER

K082817 is an FDA 510(k) clearance for PRIMUS STEAM STERILIZER, manufactured by Primus Sterilizer Company, LLC. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K082817 · Primus Sterilizer Company, LLC · General Hospital
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May 2009
Decision
238d
Days
Class 2
Risk

K082817 is an FDA 510(k) clearance for the PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Primus Sterilizer Company, LLC (Great Bend, US). The FDA issued a Cleared decision on May 21, 2009 after a review of 238 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6880 - 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 Primus Sterilizer Company, LLC devices

FDA 510(k) Submission Details - K082817

510(k) Number K082817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2008
Decision Date May 21, 2009
Days to Decision 238 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 129d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FLE Device Classification - Class 2, Special Controls

Product Code FLE Sterilizer, Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6880
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 - FLE Sterilizer, Steam

All 76
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K082817.
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AMSCO EVOLUTION MEDIUM STEAM STERILIZER
K082435 · STERIS Corporation · Dec 2008
CLS-2000 UNIT
K024133 · Dentsply Intl. · Oct 2003
AMSCO CENTURY STEAM STERILIZER
K030789 · STERIS Corporation · Mar 2003