Cleared Traditional

K921738 - SONO-VU US(TM)

K921738 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 89-day FDA review.

K921738 · E-Z-Em, Inc. · Radiology device
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Apr 1992
Decision
89d
Days
Class 1
Risk

K921738 is an FDA 510(k) clearance for the SONO-VU US(TM), MODIFICATION. Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by E-Z-Em, Inc. (Glens Falls, US). The FDA issued a Cleared decision on April 27, 1992 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all E-Z-Em, Inc. devices

Submission Details

510(k) Number K921738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1992
Decision Date April 27, 1992
Days to Decision 89 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 107d · This submission: 89d
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 K921738.
G.E. STERILE AMNIOCENTESIS TRAY
K960203 · GE Medical Systems · Mar 1996
SONO-VU US(TM)
K904583 · E-Z-Em, Inc. · Jun 1991
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