Cleared Traditional

EZ PUMP (K926446) - FDA 510(k) Clearance

Class I General Hospital device.

K926446 · Alphamed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
278d
Days
Class 1
Risk

K926446 is an FDA 510(k) clearance for the EZ PUMP. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Alphamed, Inc. (Duluth, US). The FDA issued a Cleared decision on September 27, 1993 after a review of 278 days - an extended review cycle.

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: 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 Alphamed, Inc. devices

Submission Details

510(k) Number K926446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1992
Decision Date September 27, 1993
Days to Decision 278 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 129d · This submission: 278d
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.