Cleared Special

K031799 - MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881

K031799 is an FDA 510(k) clearance for MIELE DENTAL THERMAL DISINFECTOR, manufactured by Miele, Inc.. The device is a Class 2 General Hospital device with product code LDS cleared through the Special 510(k) pathway after a 155-day FDA review.

K031799 · Miele, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K031799

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

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 10
Devices cleared under the same product code (LDS) and FDA review panel - the closest regulatory comparables to K031799.
Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
K183444 · Cenorin, LLC · Sep 2019
RELIANCE FAMILY OF WASHER-DISINFECTORS
K983068 · STERIS Corporation · May 2000
OLYMPIX MINI-PASTEURMATIC (58210)
K972193 · Olympic Medical Corp. · Sep 1997
MIELE G 7781 DENTAL THERMAL DISINFECTOR
K950518 · Miele Professional · Jan 1996
DECOMAT 4656
K950566 · Getinge Disinfection, Inc. · Oct 1995
OLYMPIC PASTEURMATIC SYSTEM
K953645 · Olympic Medical Corp. · Sep 1995
K031799 · MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
Download PDF FDA Summary Miele, Inc.