Cleared Traditional

K920063 - DISETRONIC DOLOMAT PUMP

K920063 is an FDA 510(k) clearance for DISETRONIC DOLOMAT PUMP, manufactured by Disetronic Medical Systems. The device is a Class 1 General Hospital device with product code FRW cleared through the Traditional 510(k) pathway after a 574-day FDA review.

K920063 · Disetronic Medical Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
574d
Days
Class 1
Risk

K920063 is an FDA 510(k) clearance for the DISETRONIC DOLOMAT PUMP. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Disetronic Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on August 3, 1993 after a review of 574 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2720 - 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 Disetronic Medical Systems devices

FDA 510(k) Submission Details - K920063

510(k) Number K920063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1992
Decision Date August 03, 1993
Days to Decision 574 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
445d slower than avg
Panel avg: 129d · This submission: 574d
Pathway characteristics
Predicate-based equivalence.

FRW Device Classification - Class 1, General Controls

Product Code FRW Scale, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2720
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FRW Scale, Patient

All 14
Devices cleared under the same product code (FRW) and FDA review panel - the closest regulatory comparables to K920063.
WARM-SCALE
K952649 · Olympic Medical Corp. · Aug 1995
3M MODEL 280RT RATE TAPER INFUSION PUMP
K926058 · 3M Health Care, Ltd. · Aug 1993
3M MODEL 200RT RATE TAPER INFUSION PUMP
K926059 · 3M Health Care, Ltd. · Aug 1993
SMART SCALE X-RAY PLATFORM
K904138 · Olympic Medical Corp. · Nov 1990
VAAKA BABY SCALE
K902545 · Ferguson Medical · Jul 1990
OLYMPIC SMART SCALE PEDIATRICS MODEL 50
K901522 · Olympic Medical Corp. · Jun 1990