Cleared Traditional

K851016 - PASSY-MUIR TRACH VALVE

K851016 is the FDA 510(k) clearance for PASSY-MUIR TRACH VALVE by Passy & Passy, Inc.. It is a Class 2 Anesthesiology device (product code BTO) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K851016 · Passy & Passy, Inc. · Anesthesiology device
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Jun 1985
Decision
87d
Days
Class 2
Risk

K851016 is an FDA 510(k) clearance for the PASSY-MUIR TRACH VALVE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Passy & Passy, Inc. (Irvine, US). The FDA issued a Cleared decision on June 7, 1985 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 Passy & Passy, Inc. devices

Submission Details

510(k) Number K851016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date June 07, 1985
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 24
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K851016.
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K870181 · Cook, Inc. · May 1987
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K865061 · Shiley, Inc. · Jan 1987
LGT TUBE
K852413 · Mallinckrodt Critical Care · Sep 1985
SHILEY DISPOS. CANNULA FENESTRATED LOW
K843729 · Shiley, Inc. · Oct 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · Shiley, Inc. · Oct 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832 · Shiley, Inc. · Mar 1984