Cleared Traditional

K900021 - PERCU-SET(TM) (FDA 510(k) Clearance)

Class I Obstetrics & Gynecology device.

K900021 · E-Z-Em, Inc. · Obstetrics & Gynecology device
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Mar 1990
Decision
86d
Days
Class 1
Risk

K900021 is an FDA 510(k) clearance for the PERCU-SET(TM). Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on March 29, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1550 - the FDA obstetrics and gynecology 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: 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 K900021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1990
Decision Date March 29, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 160d · This submission: 86d
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.