Cleared Traditional

K963347 - REUSABLE

K963347 is the FDA 510(k) clearance for REUSABLE by Instrumentation Industries, Inc.. It is a Class 2 Anesthesiology device (product code BYE) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K963347 · Instrumentation Industries, Inc. · Anesthesiology device
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Mar 1997
Decision
205d
Days
Class 2
Risk

K963347 is an FDA 510(k) clearance for the REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 205 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentation Industries, Inc. devices

Submission Details

510(k) Number K963347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1996
Decision Date March 19, 1997
Days to Decision 205 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 140d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 25
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K963347.
KENDALL SHERIDAN CPAP SYSTEM
K953511 · Kendall Healthcare Products Co. Div.Of Tyco Health · Oct 1995
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
K922178 · Puritan Bennett Corp. · May 1992
20CM/H20 PEEP VALVE
K912578 · Vital Signs, Inc. · Sep 1991
ADJUSTABLE PEEP VALVE
K904874 · Vital Signs, Inc. · Jan 1991
COMPANION 318 NASAL CPAP SYSTEM
K903764 · Puritan Bennett Corp. · Sep 1990
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE
K903125 · Puritan Bennett Corp. · Sep 1990