Cleared Traditional

K842464 - TRACHEAL TUBE/STETHOSCOPE

K842464 is the FDA 510(k) clearance for TRACHEAL TUBE/STETHOSCOPE by Mallinckrodt Critical Care. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K842464 · Mallinckrodt Critical Care · Anesthesiology device
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Jul 1984
Decision
11d
Days
Class 2
Risk

K842464 is an FDA 510(k) clearance for the TRACHEAL TUBE/STETHOSCOPE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 11 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K842464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1984
Decision Date July 06, 1984
Days to Decision 11 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
129d faster than avg
Panel avg: 140d · This submission: 11d
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 117
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K842464.
UNCUFFED REINFORCED TRACHEAL TUBE
K841872 · Mallinckrodt Critical Care · Jul 1984
SHERIDAN/ENDO-PAK
K842635 · Sheridan Catheter Corp. · Jul 1984
SHERIDAN/INTENSA TUBE
K842558 · Sheridan Catheter Corp. · Jul 1984
COLE TUBE-LATEX
K840973 · Inmed Corp. · Mar 1984
3-DAY BIOINDICATOR RELEASE FOR STERIL
K833831 · Shiley, Inc. · Mar 1984
ARGYLE JET TRACHEAL TUBE
K833807 · Sherwood Medical Co. · Jan 1984