Cleared Traditional

ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE (K854632) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854632 · Respiratory Support Products, Inc. · Anesthesiology device
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Jan 1986
Decision
43d
Days
Class 2
Risk

K854632 is an FDA 510(k) clearance for the ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Respiratory Support Products, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on January 3, 1986 after a review of 43 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 Respiratory Support Products, Inc. devices

Submission Details

510(k) Number K854632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1985
Decision Date January 03, 1986
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 140d · This submission: 43d
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 43
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K854632.
SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE
K861461 · Shiley, Inc. · May 1986
SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE
K861462 · Shiley, Inc. · May 1986
SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
K861463 · Shiley, Inc. · May 1986
ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE
K844564 · Sherwood Medical Co. · Feb 1985
DOUBLE CONTOURED CUFF TRACHEAL TUBE
K843714 · Ohmeda Medical · Oct 1984
3-DAY BIOINDICATOR RELEASE FOR STERIL
K833831 · Shiley, Inc. · Mar 1984