Cleared Traditional

K861461 - SHILEY SLEEP APNEA CUFFLESS FENESTRATED...

K861461 is an FDA 510(k) clearance for SHILEY SLEEP APNEA CUFFLESS FENESTRATED..., manufactured by Shiley, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K861461 · Shiley, Inc. · Anesthesiology device
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May 1986
Decision
15d
Days
Class 2
Risk

K861461 is an FDA 510(k) clearance for the SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on May 6, 1986 after a review of 15 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K861461

510(k) Number K861461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1986
Decision Date May 06, 1986
Days to Decision 15 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
125d faster than avg
Panel avg: 140d · This submission: 15d
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 133
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K861461.
ENDOTRACHEAL TUBE, ACCESSORY
K862347 · Sheridan Catheter Corp. · Jul 1986
LASER RESISTANT TRACHEAL TUBE (TENTATIVE)
K860901 · Mallinckrodt Critical Care · Jun 1986
END TIDAL CO2 TUBE
K861454 · Sheridan Catheter Corp. · 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
SPIRAL-FLEX
K860105 · Sheridan Catheter Corp. · Mar 1986