Cleared Traditional

K961167 - MEDCARE TRACHEOSTOMY CARE TRAY (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K961167 · Medcare Medical Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
15d faster than avg
Panel avg: 114d · This submission: 99d
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.