Cleared Traditional

K961977 - KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE

K961977 is an FDA 510(k) clearance for KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Anesthesiology device with product code CBI cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K961977 · Kendall Healthcare Products Co. Div.Of Tyco Health · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
72d
Days
Class 2
Risk

K961977 is an FDA 510(k) clearance for the KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on July 31, 1996 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5740 - 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K961977

510(k) Number K961977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1996
Decision Date July 31, 1996
Days to Decision 72 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 140d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBI Device Classification - Class 2, Special Controls

Product Code CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5740
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 - CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

All 21
Devices cleared under the same product code (CBI) and FDA review panel - the closest regulatory comparables to K961977.
RUSCH BRONCHUS BLOCKER KIT
K010596 · Rusch Intl. · Nov 2001
ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
K002288 · Cook, Inc. · Nov 2000
BRONCHIAL BLOCKER
K962167 · Cook, Inc. · Aug 1997
SIMS BLUE LINE ENDOBRONCHIAL TUBE
K953483 · Smiths Industries Medical Systems, Inc. · Oct 1995
SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE
K925615 · Sorin Biomedica, Fiat, USA, Inc. · Mar 1993
LASER RESISTANT TRACHEAL TUBE
K897046 · Sheridan Catheter Corp. · Mar 1990