Cleared Traditional

K922960 - VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE

K922960 is an FDA 510(k) clearance for VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, manufactured by Cameo, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HIO cleared through the Traditional 510(k) pathway after a 140-day FDA review.

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.

View all Cameo, Inc. devices

FDA 510(k) Submission Details - K922960

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.

HIO Device Classification - Class 1, General Controls

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)

All 14
Devices cleared under the same product code (HIO) and FDA review panel - the closest regulatory comparables to K922960.
G.E. STERILE AMNIOCENTESIS TRAY
K960203 · GE Medical Systems · Mar 1996
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
K955679 · Contour Fabricators of Florida, Inc. · Mar 1996
AMNIOTEST(TM)
K914419 · Pro-Lab, Inc. · Sep 1993
SONO-VU US(TM), MODIFICATION
K921738 · E-Z-Em, Inc. · Apr 1992
SONO-VU US(TM)
K904583 · E-Z-Em, Inc. · Jun 1991
PERCU-SET(TM)
K900021 · E-Z-Em, Inc. · Mar 1990