Cleared Traditional

K952925 - READY NURSE SYSTEM (RNS) TRACH CARE KIT

K952925 is an FDA 510(k) clearance for READY NURSE SYSTEM (RNS) TRACH CARE KIT, manufactured by Contour Fabricators of Florida, Inc.. The device is a Class 1 General & Plastic Surgery device with product code LRQ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K952925 · Contour Fabricators of Florida, Inc. · General & Plastic Surgery device
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Jul 1995
Decision
16d
Days
Class 1
Risk

K952925 is an FDA 510(k) clearance for the READY NURSE SYSTEM (RNS) TRACH CARE KIT. Classified as Tracheostomy And Nasal Suctioning Kit (product code LRQ), Class I - General Controls.

Submitted by Contour Fabricators of Florida, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on July 12, 1995 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 - K952925

510(k) Number K952925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 26, 1995
Decision Date July 12, 1995
Days to Decision 16 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

LRQ Device Classification - Class 1, General Controls

Product Code LRQ Tracheostomy And Nasal Suctioning Kit
Device Class Class 1 - General Controls
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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.