Cleared Traditional

K983068 - RELIANCE FAMILY OF WASHER-DISINFECTORS

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

K983068 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all STERIS Corporation devices

FDA 510(k) Submission Details - K983068

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.

LDS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LDS Device, Pasteurization, Hot Water

Devices cleared under the same product code (LDS) and FDA review panel - the closest regulatory comparables to K983068.
Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
K183444 · Cenorin, LLC · Sep 2019
OLYMPIX MINI-PASTEURMATIC (58210)
K972193 · Olympic Medical Corp. · Sep 1997
MIELE G 7781 DENTAL THERMAL DISINFECTOR
K950518 · Miele Professional · Jan 1996
OLYMPIC PASTEURMATIC SYSTEM
K953645 · Olympic Medical Corp. · Sep 1995
CASTLE 7538 FLOOR LOADING WASHER
K860263 · Castle Co. · Mar 1986
CASTLE 7515 UTENSIL/GLASSWARE WASHER
K844089 · Castle Co. · Jan 1985