Cleared Traditional

K833197 - TRACH SWIVE/CONNECTOR

K833197 is the FDA 510(k) clearance for TRACH SWIVE/CONNECTOR by Airlife, Inc.. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K833197 · Airlife, Inc. · Anesthesiology device
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Oct 1983
Decision
39d
Days
Class 2
Risk

K833197 is an FDA 510(k) clearance for the TRACH SWIVE/CONNECTOR. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 39 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 Airlife, Inc. devices

Submission Details

510(k) Number K833197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1983
Decision Date October 28, 1983
Days to Decision 39 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
101d faster than avg
Panel avg: 140d · This submission: 39d
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 59
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K833197.
TRACHEAL TUBE/STETHOSCOPE
K842464 · Mallinckrodt Critical Care · Jul 1984
3-DAY BIOINDICATOR RELEASE FOR STERIL
K833831 · Shiley, Inc. · Mar 1984
ARGYLE JET TRACHEAL TUBE
K833807 · Sherwood Medical Co. · Jan 1984
TRACHEAL TUBE W/ILLUMINATING LOCATER
K830631 · Mallinckrodt Critical Care · May 1983
ARGYLE TARTAN I TRACHEAL TUBE
K821670 · Sherwood Medical Co. · Jun 1982
TRACELON
K821180 · Terumo Medical Corp. · May 1982