Cleared Traditional

K884151 - MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.

K884151 is an FDA 510(k) clearance for MODEL G7731D WASHER/DISINFECTOR FOR DEN..., manufactured by Miele Appliances, Inc.. The device is a Class 2 General Hospital device with product code LDS cleared through the Traditional 510(k) pathway after a 225-day FDA review.

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

FDA 510(k) Submission Details - K884151

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.

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

All 7
Devices cleared under the same product code (LDS) and FDA review panel - the closest regulatory comparables to K884151.
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