Cleared Traditional

K982332 - STERIS TEN SIXTEEN STEAM STERILIZER

K982332 is the FDA 510(k) clearance for STERIS TEN SIXTEEN STEAM STERILIZER by STERIS Corporation. It is a Class 2 General Hospital device (product code FLE) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K982332 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
202d
Days
Class 2
Risk

K982332 is an FDA 510(k) clearance for the STERIS TEN SIXTEEN STEAM STERILIZER. Classified as Sterilizer, Steam (product code FLE), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on January 20, 1999 after a review of 202 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 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 Corporation devices

Submission Details

510(k) Number K982332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1998
Decision Date January 20, 1999
Days to Decision 202 days
Submission Type Traditional
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
73d slower than avg
Panel avg: 129d · This submission: 202d
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 K982332.
AMSCO CENTURY MEDIUM STERILIZER 26 X 26
K020747 · STERIS Corporation · May 2002
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
K010865 · STERIS Corporation · May 2001
STERIS AMSCO MILLENNIUM STEAM STERILIZER
K000077 · STERIS Corporation · Mar 2000
THE SYSTEM 2S STEAM STERILIZER
K980014 · STERIS Corporation · May 1998
STERRADD STERILIZATION SYSTEM
K954142 · Advanced Sterilization Products · Jun 1997
STRYKER ENCORE STERILIZER
K962755 · Stryker Corp. · Mar 1997