Cleared Traditional

K902116 - MODIFIED ENDOBRONCHIAL TUBE

K902116 is an FDA 510(k) clearance for MODIFIED ENDOBRONCHIAL TUBE, manufactured by Concord/Portex. The device is a Class 2 Anesthesiology device with product code BTS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K902116 · Concord/Portex · Anesthesiology device
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Aug 1990
Decision
85d
Days
Class 2
Risk

K902116 is an FDA 510(k) clearance for the MODIFIED ENDOBRONCHIAL TUBE. Classified as Tube, Bronchial (w/wo Connector) (product code BTS), Class II - Special Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on August 3, 1990 after a review of 85 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 Concord/Portex devices

FDA 510(k) Submission Details - K902116

510(k) Number K902116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1990
Decision Date August 03, 1990
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 K902116.
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
ENDOBRONCHIAL TWIN LUMEN TUBE
K834565 · Portex, Inc. · Jan 1984
BRONCHOSCOPY TUBE W/ULTRA LOCUFF
K833297 · Surgitek · Dec 1983
BRONCHO-CATH
K771219 · Mallinckrodt Critical Care · Aug 1977