Cleared Traditional

K834565 - ENDOBRONCHIAL TWIN LUMEN TUBE

K834565 is an FDA 510(k) clearance for ENDOBRONCHIAL TWIN LUMEN TUBE, manufactured by Portex, Inc.. The device is a Class 2 Anesthesiology device with product code BTS cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K834565 · Portex, Inc. · Anesthesiology device
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Jan 1984
Decision
20d
Days
Class 2
Risk

K834565 is an FDA 510(k) clearance for the ENDOBRONCHIAL TWIN LUMEN TUBE. Classified as Tube, Bronchial (w/wo Connector) (product code BTS), Class II - Special Controls.

Submitted by Portex, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1984 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5720 - 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 Portex, Inc. devices

FDA 510(k) Submission Details - K834565

510(k) Number K834565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1983
Decision Date January 17, 1984
Days to Decision 20 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
120d faster than avg
Panel avg: 140d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTS Device Classification - Class 2, Special Controls

Product Code BTS Tube, Bronchial (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5720
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 - BTS Tube, Bronchial (w/wo Connector)

Devices cleared under the same product code (BTS) and FDA review panel - the closest regulatory comparables to K834565.
RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION
K953963 · Rusch, Inc. · Nov 1995
RUSCH ENDOBRONCHIAL TUBE SETS
K951091 · Rusch Intl. · Jun 1995
MODIFIED ENDOBRONCHIAL TUBE
K902116 · Concord/Portex · Aug 1990
BRONCHOSCOPY TUBE W/ULTRA LOCUFF
K833297 · Surgitek · Dec 1983
BRONCHO-CATH
K771219 · Mallinckrodt Critical Care · Aug 1977