Cleared Traditional

K860901 - LASER RESISTANT TRACHEAL TUBE (TENTATIVE)

K860901 is the FDA 510(k) clearance for LASER RESISTANT TRACHEAL TUBE (TENTATIVE) by Mallinckrodt Critical Care. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K860901 · Mallinckrodt Critical Care · Anesthesiology device
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Jun 1986
Decision
87d
Days
Class 2
Risk

K860901 is an FDA 510(k) clearance for the LASER RESISTANT TRACHEAL TUBE (TENTATIVE). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Glens Falls, US). The FDA issued a Cleared decision on June 5, 1986 after a review of 87 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 K860901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1986
Decision Date June 05, 1986
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 K860901.
BIVONA FOME-CUF LASER ENDOTRACHEAL TUBE
K862238 · Bivona Medical Technologies · Oct 1986
UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
K862666 · Mallinckrodt Critical Care · Aug 1986
ENDOTRACHEAL TUBE, ACCESSORY
K862347 · Sheridan Catheter Corp. · Jul 1986
END TIDAL CO2 TUBE
K861454 · Sheridan Catheter Corp. · May 1986
SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE
K861461 · Shiley, Inc. · May 1986
SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE
K861462 · Shiley, Inc. · May 1986