Cleared Traditional

K983068 - RELIANCE FAMILY OF WASHER-DISINFECTORS

K983068 is the FDA 510(k) clearance for RELIANCE FAMILY OF WASHER-DISINFECTORS by STERIS Corporation. It is a Class 2 General Hospital device (product code LDS) cleared through the Traditional 510(k) pathway after a 637-day FDA review.

K983068 · STERIS Corporation · General Hospital
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May 2000
Decision
637d
Days
Class 2
Risk

K983068 is an FDA 510(k) clearance for the RELIANCE FAMILY OF WASHER-DISINFECTORS. Classified as Device, Pasteurization, Hot Water (product code LDS), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 31, 2000 after a review of 637 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6991 - 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.

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Submission Details

510(k) Number K983068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1998
Decision Date May 31, 2000
Days to Decision 637 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
508d slower than avg
Panel avg: 129d · This submission: 637d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDS Device, Pasteurization, Hot Water
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6991
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.