Cleared Traditional

STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT (K875280) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K875280 · Steris C/O Medical Device Consultants, Inc. · General Hospital
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Sep 1988
Decision
264d
Days
Class 2
Risk

K875280 is an FDA 510(k) clearance for the STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT. Classified as Sterilant, Medical Devices (product code MED), Class II - Special Controls.

Submitted by Steris C/O Medical Device Consultants, Inc. (North Attleboro, US). The FDA issued a Cleared decision on September 13, 1988 after a review of 264 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6885 - 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 Steris C/O Medical Device Consultants, Inc. devices

Submission Details

510(k) Number K875280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1987
Decision Date September 13, 1988
Days to Decision 264 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 129d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MED Sterilant, Medical Devices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6885
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.