Cleared Traditional

K844564 - ARGYLE LASER RESISTANT TRACHEAL TUBE W/...

K844564 is the FDA 510(k) clearance for ARGYLE LASER RESISTANT TRACHEAL TUBE W/... by Sherwood Medical Co.. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K844564 · Sherwood Medical Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
81d
Days
Class 2
Risk

K844564 is an FDA 510(k) clearance for the ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on February 12, 1985 after a review of 81 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K844564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date February 12, 1985
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 140d · This submission: 81d
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 107
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K844564.
VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY
K853502 · Bivona Medical Technologies · Oct 1985
BRANDT TRACHEAL TUBE(TENTATIVE)
K852025 · Mallinckrodt Critical Care · Aug 1985
UNCUFFED HI-LO JET TRACHEAL TUBE
K852493 · Mallinckrodt Critical Care · Jul 1985
TRACHEAL TUBE W/AIRWAY INTUBATOR
K844746 · Sheridan Catheter Corp. · Jan 1985
TRACHEAL TUBE, REINFORCED, CUFFED
K844296 · Sheridan Catheter Corp. · Dec 1984
DOUBLE CONTOURED CUFF TRACHEAL TUBE
K843714 · Ohmeda Medical · Oct 1984