Cleared Traditional

K830504 - SURGITEK ULTRA-LO CUFF

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

K830504 · Mec/Surgitek Products · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K830504

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.

BTR Device Classification - Class 2, Special Controls

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 206
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K830504.
TRACH SWIVE/CONNECTOR
K833197 · Airlife, Inc. · Oct 1983
TRACHEAL TUBE W/ILLUMINATING LOCATER
K830631 · Mallinckrodt Critical Care · May 1983
SURGITEK ENDOTRACHEAL TUBE, LASER RESIS
K823757 · Medical Engineering Corp. · Apr 1983
REINFORCED SILICONE TRACHEAL TUBE
K830352 · Portex, Inc. · Mar 1983
SHERIDAN/HVT,CF, UNCUFFED
K822082 · Sheridan Catheter Corp. · Aug 1982
ARGYLE TARTAN I TRACHEAL TUBE
K821670 · Sherwood Medical Co. · Jun 1982