Cleared Traditional

K954142 - STERRADD STERILIZATION SYSTEM

K954142 is the FDA 510(k) clearance for STERRADD STERILIZATION SYSTEM by Advanced Sterilization Products. It is a Class 2 General Hospital device (product code FLE) cleared through the Traditional 510(k) pathway after a 644-day FDA review.

K954142 · Advanced Sterilization Products · General Hospital
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Jun 1997
Decision
644d
Days
Class 2
Risk

K954142 is an FDA 510(k) clearance for the STERRADD STERILIZATION SYSTEM. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on June 6, 1997 after a review of 644 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 Advanced Sterilization Products devices

Submission Details

510(k) Number K954142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1995
Decision Date June 06, 1997
Days to Decision 644 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
515d slower than avg
Panel avg: 129d · This submission: 644d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 66
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K954142.
STERIS AMSCO MILLENNIUM STEAM STERILIZER
K000077 · STERIS Corporation · Mar 2000
STERIS TEN SIXTEEN STEAM STERILIZER
K982332 · STERIS Corporation · Jan 1999
THE SYSTEM 2S STEAM STERILIZER
K980014 · STERIS Corporation · May 1998
STRYKER ENCORE STERILIZER
K962755 · Stryker Corp. · Mar 1997
DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY
K920293 · Davis & Geck, Inc. · Apr 1992
RITTER STERILIZER
K801309 · Sybron Corp. · Jun 1980