Cleared Traditional

K830504 - SURGITEK ULTRA-LO CUFF

K830504 is the FDA 510(k) clearance for SURGITEK ULTRA-LO CUFF by Mec/Surgitek Products. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K830504 · Mec/Surgitek Products · Anesthesiology device
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Apr 1983
Decision
55d
Days
Class 2
Risk

K830504 is an FDA 510(k) clearance for the SURGITEK ULTRA-LO CUFF. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mec/Surgitek Products (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 55 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 Mec/Surgitek Products devices

Submission Details

510(k) Number K830504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1983
Decision Date April 12, 1983
Days to Decision 55 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 140d · This submission: 55d
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 66
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K830504.
ARGYLE JET TRACHEAL TUBE
K833807 · Sherwood Medical Co. · Jan 1984
TRACH SWIVE/CONNECTOR
K833197 · Airlife, Inc. · Oct 1983
TRACHEAL TUBE W/ILLUMINATING LOCATER
K830631 · Mallinckrodt Critical Care · May 1983
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