Cleared Traditional

K952925 - READY NURSE SYSTEM (RNS) TRACH CARE KIT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

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

Submission Details

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
98d faster than avg
Panel avg: 114d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.