Cleared Traditional

K843714 - DOUBLE CONTOURED CUFF TRACHEAL TUBE

K843714 is the FDA 510(k) clearance for DOUBLE CONTOURED CUFF TRACHEAL TUBE by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K843714 · Ohmeda Medical · Anesthesiology device

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Oct 1984

Decision

25d

Days

Class 2

Risk

K843714 is an FDA 510(k) clearance for the DOUBLE CONTOURED CUFF TRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on October 19, 1984 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Ohmeda Medical devices

Submission Details

510(k) Number	K843714 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 24, 1984
Decision Date	October 19, 1984
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

115d faster than avg

Panel avg: 140d · This submission: 25d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	BTR Tube, Tracheal (w/wo Connector)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 868.5730

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 - BTR Tube, Tracheal (w/wo Connector)

All 107

Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K843714.

ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE

K844564 · Sherwood Medical Co. · Feb 1985

TRACHEAL TUBE W/AIRWAY INTUBATOR

K844746 · Sheridan Catheter Corp. · Jan 1985

TRACHEAL TUBE, REINFORCED, CUFFED

K844296 · Sheridan Catheter Corp. · Dec 1984

UNCUFFED REINFORCED TRACHEAL TUBE

K841872 · Mallinckrodt Critical Care · Jul 1984

SHERIDAN/ENDO-PAK

K842635 · Sheridan Catheter Corp. · Jul 1984

SHERIDAN/INTENSA TUBE

K842558 · Sheridan Catheter Corp. · Jul 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K843714

Ohmeda Medical

Madison, WI · US

RAYMOND T RIDDLE

Regulatory profile

120 submissions 118 cleared

98% clearance rate · Active in Anesthesiology

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Sourced from FDA 510(k) public files . Updated monthly.

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