Cleared Traditional

K844696 - TROGIDE

K844696 is the FDA 510(k) clearance for TROGIDE by Carmel Medical Devices. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K844696 · Carmel Medical Devices · Anesthesiology device
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Mar 1985
Decision
91d
Days
Class 2
Risk

K844696 is an FDA 510(k) clearance for the TROGIDE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Carmel Medical Devices (Carmel, US). The FDA issued a Cleared decision on March 4, 1985 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carmel Medical Devices devices

Submission Details

510(k) Number K844696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1984
Decision Date March 04, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
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 62
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K844696.
SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
K861463 · Shiley, Inc. · May 1986
BRANDT TRACHEAL TUBE(TENTATIVE)
K852025 · Mallinckrodt Critical Care · Aug 1985
UNCUFFED HI-LO JET TRACHEAL TUBE
K852493 · Mallinckrodt Critical Care · Jul 1985
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