Cleared Traditional

MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU. (K884151) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K884151 · Miele Appliances, Inc. · General Hospital
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May 1989
Decision
225d
Days
Class 2
Risk

K884151 is an FDA 510(k) clearance for the MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.. Classified as Device, Pasteurization, Hot Water (product code LDS), Class II - Special Controls.

Submitted by Miele Appliances, Inc. (Somerset, US). The FDA issued a Cleared decision on May 16, 1989 after a review of 225 days - an extended review cycle.

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: 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 Miele Appliances, Inc. devices

Submission Details

510(k) Number K884151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1988
Decision Date May 16, 1989
Days to Decision 225 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 129d · This submission: 225d
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.