Cleared Traditional

K952416 - TRACHEOSTOMY CARE KIT

K952416 is the FDA 510(k) clearance for TRACHEOSTOMY CARE KIT by Medi-Flex Hospital Products, Inc.. It is a Class 2 Anesthesiology device (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

Submission Details

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.

Device Classification

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 23
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K952416.
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm
K192511 · Venner Medical (Singapore) Pte, Ltd. · Jul 2020
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
K173384 · Smiths Medical Ads, Inc. · Apr 2018
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
K100283 · Cook, Inc. · Apr 2010
SHILEY PHONATION VALVE
K900548 · Shiley, Inc. · Apr 1990
SHILEY PERC TRACHEOSTOMY SYSTEM
K884730 · Shiley, Inc. · Jan 1989
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
K880614 · Shiley, Inc. · Mar 1988