Cleared Traditional

K952416 - TRACHEOSTOMY CARE KIT

K952416 is an FDA 510(k) clearance for TRACHEOSTOMY CARE KIT, manufactured by Medi-Flex Hospital Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K952416 · Medi-Flex Hospital Products, Inc. · Anesthesiology device
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Aug 1995
Decision
78d
Days
Class 2
Risk

K952416 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE KIT. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Medi-Flex Hospital Products, Inc. (El Paso, US). The FDA issued a Cleared decision on August 9, 1995 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - the FDA anesthesiology and respiratory 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 Medi-Flex Hospital Products, Inc. devices

FDA 510(k) Submission Details - K952416

510(k) Number K952416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 23, 1995
Decision Date August 09, 1995
Days to Decision 78 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 140d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTO Tube, Tracheostomy (w/wo Connector)

All 59
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K952416.
CRICOTHYROTOMY TUBE
K983000 · Polamedco, Inc. · Oct 1999
CPR TRACHEOTOMY CARE TRAY
K960205 · Custom Pack Reliability · Aug 1996
MOORE TRACHEOSTOMY TUBE
K962240 · Boston Medical Products, Inc. · Aug 1996
LOW PROFILE TRACHEOSTOMY TUBE
K922749 · Concord/Portex · Sep 1992
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
K920281 · Trinity Laboratories, Inc. · Aug 1992
TRACHEOSTOMY CARE KIT
K921281 · Trinity Laboratories, Inc. · Aug 1992