Cleared Traditional

DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA (K970811) - FDA 510(k) Clearance

Also marketed or referenced as:
DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970811 · Pneumocare, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Nov 1998
Decision
618d
Days
Class 2
Risk

K970811 is an FDA 510(k) clearance for the DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Pneumocare, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on November 13, 1998 after a review of 618 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Pneumocare, Inc. devices

Submission Details

510(k) Number K970811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1997
Decision Date November 13, 1998
Days to Decision 618 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
478d slower than avg
Panel avg: 140d · This submission: 618d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOH Tube Tracheostomy And Tube Cuff
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 - JOH Tube Tracheostomy And Tube Cuff

All 20
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K970811.
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
K093469 · Cook, Inc. · Jan 2010
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148 · Cook, Inc. · Oct 2007
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044 · Cook, Inc. · Jul 2004
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K903435 · Shiley, Inc. · Oct 1990
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K890194 · Shiley, Inc. · Jul 1989
SHILEY FENESTRATED LOW PRESS. CUFFED
K812302 · Shiley, Inc. · Sep 1981