Cleared Traditional

K982332 - STERIS TEN SIXTEEN STEAM STERILIZER

K982332 is an FDA 510(k) clearance for STERIS TEN SIXTEEN STEAM STERILIZER, manufactured by STERIS Corporation. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K982332

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.

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 123
Devices cleared under the same product code (FLE) and FDA review panel - the closest regulatory comparables to K982332.
MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
K992744 · Midmark Corp. · Jan 2000
PRIMUS STEAM STERILIZERS
K991575 · Primus Sterilizer Co., Inc. · Dec 1999
MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K990189 · Midmark Corp. · Apr 1999
STATIM 5000 CASSETTE AUTOCLAVE
K983679 · Scican · Jan 1999
EAGLE CENTURY STEAM STERILIZER
K964332 · Amsco Intl., Inc. · Jun 1998
THE SYSTEM 2S STEAM STERILIZER
K980014 · STERIS Corporation · May 1998