Cleared Special

MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 (K031799) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031799 · Miele, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
155d
Days
Class 2
Risk

K031799 is an FDA 510(k) clearance for the MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881. Classified as Device, Pasteurization, Hot Water (product code LDS), Class II - Special Controls.

Submitted by Miele, Inc. (Princeton, US). The FDA issued a Cleared decision on November 12, 2003 after a review of 155 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Miele, Inc. devices

Submission Details

510(k) Number K031799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2003
Decision Date November 12, 2003
Days to Decision 155 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

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.