Cleared Traditional

K904583 - SONO-VU US(TM)

K904583 is the FDA 510(k) clearance for SONO-VU US(TM) by E-Z-Em, Inc.. It is a Class 1 Radiology device (product code HIO) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K904583 · E-Z-Em, Inc. · Radiology device
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Jun 1991
Decision
258d
Days
Class 1
Risk

K904583 is an FDA 510(k) clearance for the SONO-VU US(TM). Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by E-Z-Em, Inc. (Worcester, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 258 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.1550 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K904583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1990
Decision Date June 24, 1991
Days to Decision 258 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 107d · This submission: 258d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HIO Sampler, Amniotic Fluid (amniocentesis Tray)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.1550
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 - HIO Sampler, Amniotic Fluid (amniocentesis Tray)

Devices cleared under the same product code (HIO) and FDA review panel - the closest regulatory comparables to K904583.
G.E. STERILE AMNIOCENTESIS TRAY
K960203 · GE Medical Systems · Mar 1996
SONO-VU US(TM), MODIFICATION
K921738 · E-Z-Em, Inc. · Apr 1992
PERCU-SET(TM)
K900021 · E-Z-Em, Inc. · Mar 1990
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031 · Baxter Healthcare Corp · Aug 1989
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
K892846 · Cook Ob/Gyn · Jul 1989
HURWITZ AMNIOCENTESIS NEEDLE
K854725 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1986