Cleared Traditional

DISETRONIC DOLOMAT PUMP (K920063) - FDA 510(k) Clearance

Class I General Hospital device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
445d slower than avg
Panel avg: 129d · This submission: 574d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.