Cleared Traditional

K955679 - RNS STERILE

K955679 is an FDA 510(k) clearance for RNS STERILE, manufactured by Contour Fabricators of Florida, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HIO cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K955679 · Contour Fabricators of Florida, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
89d
Days
Class 1
Risk

K955679 is an FDA 510(k) clearance for the RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY. Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by Contour Fabricators of Florida, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on March 12, 1996 after a review of 89 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 Contour Fabricators of Florida, Inc. devices

FDA 510(k) Submission Details - K955679

510(k) Number K955679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1995
Decision Date March 12, 1996
Days to Decision 89 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
71d faster than avg
Panel avg: 160d · This submission: 89d
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 8
Devices cleared under the same product code (HIO) and FDA review panel - the closest regulatory comparables to K955679.
G.E. STERILE AMNIOCENTESIS TRAY
K960203 · GE Medical Systems · 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
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031 · Baxter Healthcare Corp · Aug 1989