Cleared Traditional

BRANDT TRACHEAL TUBE(TENTATIVE) (K852025) - FDA 510(k) Clearance

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

K852025 · Mallinckrodt Critical Care · Anesthesiology device
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Aug 1985
Decision
97d
Days
Class 2
Risk

K852025 is an FDA 510(k) clearance for the BRANDT 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 August 13, 1985 after a review of 97 days - within the typical 510(k) review window.

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: 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

Submission Details

510(k) Number K852025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1985
Decision Date August 13, 1985
Days to Decision 97 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 139d · This submission: 97d
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 K852025.
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
ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE
K844564 · Sherwood Medical Co. · Feb 1985
3-DAY BIOINDICATOR RELEASE FOR STERIL
K833831 · Shiley, Inc. · Mar 1984
ARGYLE JET TRACHEAL TUBE
K833807 · Sherwood Medical Co. · Jan 1984