Cleared Traditional

K811888 - LINDHOLM ANATOMICAL TRACHEAL TUBE

K811888 is the FDA 510(k) clearance for LINDHOLM ANATOMICAL 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 22-day FDA review.

K811888 · Mallinckrodt Critical Care · Anesthesiology device
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Jul 1981
Decision
22d
Days
Class 2
Risk

K811888 is an FDA 510(k) clearance for the LINDHOLM ANATOMICAL TRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on July 23, 1981 after a review of 22 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 K811888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date July 23, 1981
Days to Decision 22 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
118d faster than avg
Panel avg: 140d · This submission: 22d
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 K811888.
TRACELON
K821180 · Terumo Medical Corp. · May 1982
SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL
K821027 · Shiley, Inc. · May 1982
ARGYLE TARTAN TRACHEAL TUBE
K811937 · Sherwood Medical Co. · Jul 1981
CONCEPT ENDOTRACHEAL TUBE
K801213 · Concept, Inc. · May 1980
OHIO DISPOSABLE TRACHEAL TUBE
K800634 · Ohio Medical Products · Apr 1980
FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE
K792035 · Bivona Medical Technologies · Oct 1979