Cleared Traditional

LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (K873461) - FDA 510(k) Clearance

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

K873461 · Mallinckrodt Critical Care · Anesthesiology device
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Nov 1987
Decision
70d
Days
Class 2
Risk

K873461 is an FDA 510(k) clearance for the LASER-FLEX(TM) TRACHEAL TUBE (CUFFED). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Argyle, US). The FDA issued a Cleared decision on November 6, 1987 after a review of 70 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 K873461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1987
Decision Date November 06, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 139d · This submission: 70d
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 37
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K873461.
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
K080170 · C.R. Bard, Inc. · Mar 2008
AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE
K071365 · C.R. Bard, Inc. · Nov 2007
BARD ENDOTRACHEAL TUBE, CUFFED
K030792 · C.R. Bard, Inc. · Nov 2003
SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE
K861461 · Shiley, Inc. · May 1986
SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE
K861462 · Shiley, Inc. · May 1986
SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
K861463 · Shiley, Inc. · May 1986