Cleared Traditional

K961167 - MEDCARE TRACHEOSTOMY CARE TRAY

K961167 is an FDA 510(k) clearance for MEDCARE TRACHEOSTOMY CARE TRAY, manufactured by Medcare Medical Group, Inc.. The device is a Class 1 General & Plastic Surgery device with product code LRQ cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K961167 · Medcare Medical Group, Inc. · General & Plastic Surgery device
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Jul 1996
Decision
99d
Days
Class 1
Risk

K961167 is an FDA 510(k) clearance for the MEDCARE TRACHEOSTOMY CARE TRAY. Classified as Tracheostomy And Nasal Suctioning Kit (product code LRQ), Class I - General Controls.

Submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on July 2, 1996 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medcare Medical Group, Inc. devices

FDA 510(k) Submission Details - K961167

510(k) Number K961167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 25, 1996
Decision Date July 02, 1996
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
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.