Cleared Traditional

K854632 - ENDOTRACHEAL TUBE GUIDE OR INTUBATION S...

K854632 is an FDA 510(k) clearance for ENDOTRACHEAL TUBE GUIDE OR INTUBATION S..., manufactured by Respiratory Support Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 43-day FDA review.

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

FDA 510(k) Submission Details - K854632

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
Combination Product No
PCCP Authorized No
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.

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 147
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K854632.
SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE
K861462 · Shiley, Inc. · May 1986
SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE
K861463 · Shiley, Inc. · May 1986
SPIRAL-FLEX
K860105 · Sheridan Catheter Corp. · Mar 1986
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