Cleared Abbreviated

K093333 - PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8

K093333 is an FDA 510(k) clearance for PRIMUS STEAM STERILIZER PSS8-AA (16X16X..., manufactured by Primus Sterilizer Company, LLC. The device is a Class 2 General Hospital device with product code FLE cleared through the Abbreviated 510(k) pathway after a 158-day FDA review.

K093333 · Primus Sterilizer Company, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
158d
Days
Class 2
Risk

K093333 is an FDA 510(k) clearance for the PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/L.... Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Primus Sterilizer Company, LLC (Omaha, US). The FDA issued a Cleared decision on April 2, 2010 after a review of 158 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Primus Sterilizer Company, LLC devices

FDA 510(k) Submission Details - K093333

510(k) Number K093333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2009
Decision Date April 02, 2010
Days to Decision 158 days
Submission Type Abbreviated
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
29d slower than avg
Panel avg: 129d · This submission: 158d
Pathway characteristics
Standards-based clearance path.

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 144
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