Cleared Abbreviated

K093333 - PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 128d · This submission: 158d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 183
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K093333.
Enbio PRO
K260254 · Enbio Group AG · Feb 2026
Getinge GSS67N Series Steam Sterilizer
K252307 · Maquet GmbH (A Getinge Group Company) · Jan 2026
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
K250168 · Lucas Lifecare · Dec 2025
Cassette Autoclave (ACA5)
K250164 · Guangzhou Ajax Medical Equipment Co., Ltd. · Aug 2025
Steam Sterilizer (2545D)
K243994 · Ningbo Ican Machines Co., Ltd. · Jun 2025
FRONT-LINE Field Sterilizer (FL135)
K243801 · Fort Defiance Industries, LLC · Mar 2025