Cleared Traditional

K842635 - SHERIDAN/ENDO-PAK

K842635 is the FDA 510(k) clearance for SHERIDAN/ENDO-PAK by Sheridan Catheter Corp.. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K842635 · Sheridan Catheter Corp. · Anesthesiology device
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Jul 1984
Decision
16d
Days
Class 2
Risk

K842635 is an FDA 510(k) clearance for the SHERIDAN/ENDO-PAK. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Sheridan Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on July 25, 1984 after a review of 16 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 Sheridan Catheter Corp. devices

Submission Details

510(k) Number K842635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1984
Decision Date July 25, 1984
Days to Decision 16 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 140d · This submission: 16d
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 60
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K842635.
ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE
K844564 · Sherwood Medical Co. · Feb 1985
DOUBLE CONTOURED CUFF TRACHEAL TUBE
K843714 · Ohmeda Medical · Oct 1984
UNCUFFED REINFORCED TRACHEAL TUBE
K841872 · Mallinckrodt Critical Care · Jul 1984
TRACHEAL TUBE/STETHOSCOPE
K842464 · Mallinckrodt Critical Care · Jul 1984
3-DAY BIOINDICATOR RELEASE FOR STERIL
K833831 · Shiley, Inc. · Mar 1984
ARGYLE JET TRACHEAL TUBE
K833807 · Sherwood Medical Co. · Jan 1984