Cleared Traditional

K926185 - PRIMUS PSS SERIES STERILIZERS

K926185 is an FDA 510(k) clearance for PRIMUS PSS SERIES STERILIZERS, manufactured by Primus Sterilizer Co., Inc.. The device is a Class 2 General Hospital device with product code FLE cleared through the Traditional 510(k) pathway after a 517-day FDA review.

K926185 · Primus Sterilizer Co., Inc. · General Hospital
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May 1994
Decision
517d
Days
Class 2
Risk

K926185 is an FDA 510(k) clearance for the PRIMUS PSS SERIES STERILIZERS. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Primus Sterilizer Co., Inc. (Omaha, US). The FDA issued a Cleared decision on May 9, 1994 after a review of 517 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Primus Sterilizer Co., Inc. devices

FDA 510(k) Submission Details - K926185

510(k) Number K926185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1992
Decision Date May 09, 1994
Days to Decision 517 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
388d slower than avg
Panel avg: 129d · This submission: 517d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 106
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