Cleared Traditional

K852413 - LGT TUBE

K852413 is an FDA 510(k) clearance for LGT TUBE, manufactured by Mallinckrodt Critical Care. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K852413 · Mallinckrodt Critical Care · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
91d
Days
Class 2
Risk

K852413 is an FDA 510(k) clearance for the LGT TUBE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Glens Falls, US). The FDA issued a Cleared decision on September 5, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mallinckrodt Critical Care devices

FDA 510(k) Submission Details - K852413

510(k) Number K852413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1985
Decision Date September 05, 1985
Days to Decision 91 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
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 70
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K852413.
LARYNGECTOMY TUBE, CUFFED
K860176 · Sheridan Catheter Corp. · Jan 1986
THE HOOD LIFE SAVER
K853511 · Hood Laboratories · Dec 1985
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
K853419 · Hood Laboratories · Dec 1985
BIVONA TRACHEOSTOMA VALVE II
K852272 · Bivona Medical Technologies · Jul 1985
SHILEY DISPOS. CANNULA FENESTRATED LOW
K843729 · Shiley, Inc. · Oct 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · Shiley, Inc. · Oct 1984