Cleared Traditional

K852493 - UNCUFFED HI-LO JET TRACHEAL TUBE

K852493 is the FDA 510(k) clearance for UNCUFFED HI-LO JET TRACHEAL TUBE by Mallinckrodt Critical Care. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K852493 · Mallinckrodt Critical Care · Anesthesiology device
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Jul 1985
Decision
26d
Days
Class 2
Risk

K852493 is an FDA 510(k) clearance for the UNCUFFED HI-LO JET TRACHEAL TUBE. 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 July 8, 1985 after a review of 26 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 K852493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date July 08, 1985
Days to Decision 26 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
114d faster than avg
Panel avg: 140d · This submission: 26d
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 K852493.
SPIRAL-FLEX
K860105 · Sheridan Catheter Corp. · Mar 1986
VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY
K853502 · Bivona Medical Technologies · Oct 1985
BRANDT TRACHEAL TUBE(TENTATIVE)
K852025 · Mallinckrodt Critical Care · Aug 1985
ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE
K844564 · Sherwood Medical Co. · Feb 1985
TRACHEAL TUBE W/AIRWAY INTUBATOR
K844746 · Sheridan Catheter Corp. · Jan 1985
MONTGOMERY SAFE-T-TUBE
K843936 · Boston Medical Products, Inc. · Dec 1984