Cleared Traditional

K952406 - REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC...

K952406 is an FDA 510(k) clearance for REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC..., manufactured by Contour Fabricators of Florida, Inc.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K952406 · Contour Fabricators of Florida, Inc. · General Hospital
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Aug 1995
Decision
77d
Days
Class 1
Risk

K952406 is an FDA 510(k) clearance for the REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM C.... Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Contour Fabricators of Florida, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on August 7, 1995 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6960 - the FDA general hospital 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 - K952406

510(k) Number K952406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1995
Decision Date August 07, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

KYZ Device Classification - Class 1, General Controls

Product Code KYZ Syringe, Irrigating (non Dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6960
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 - KYZ Syringe, Irrigating (non Dental)

All 15
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K952406.
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