Cleared Traditional

TRACHEAL TUBE W/ILLUMINATING LOCATER (K830631) - FDA 510(k) Clearance

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

K830631 · Mallinckrodt Critical Care · Anesthesiology device
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May 1983
Decision
69d
Days
Class 2
Risk

K830631 is an FDA 510(k) clearance for the TRACHEAL TUBE W/ILLUMINATING LOCATER. 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 May 9, 1983 after a review of 69 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 K830631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1983
Decision Date May 09, 1983
Days to Decision 69 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 139d · This submission: 69d
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 K830631.
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
ARGYLE TARTAN I TRACHEAL TUBE
K821670 · Sherwood Medical Co. · Jun 1982
TRACELON
K821180 · Terumo Medical Corp. · May 1982
SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL
K821027 · Shiley, Inc. · May 1982