Cleared Traditional

VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE (K922960) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K922960 · Cameo, Inc. · Obstetrics & Gynecology device
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Nov 1992
Decision
140d
Days
Class 1
Risk

K922960 is an FDA 510(k) clearance for the VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE. Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by Cameo, Inc. (Toledo, US). The FDA issued a Cleared decision on November 5, 1992 after a review of 140 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K922960 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received June 18, 1992
Decision Date November 05, 1992
Days to Decision 140 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 160d · This submission: 140d
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.