Cleared Traditional

K983631 - AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P

K983631 is an FDA 510(k) clearance for AUTO-PEEP MEASUREMENT DEVICE, manufactured by Instrumentation Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K983631 · Instrumentation Industries, Inc. · Anesthesiology device
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Jul 1999
Decision
259d
Days
Class 2
Risk

K983631 is an FDA 510(k) clearance for the AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on July 1, 1999 after a review of 259 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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

FDA 510(k) Submission Details - K983631

510(k) Number K983631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date July 01, 1999
Days to Decision 259 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
119d slower than avg
Panel avg: 140d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 62
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K983631.
HI-OX
K020665 · Sensor Medics Corp. · Jul 2002
RUSCH EMERGENCY MASK
K993528 · Rusch, Inc. · May 2000
FACE-2-FACE CPR PROTECTION SHIELD
K991617 · Whiteline Plastics, Inc. · Nov 1999
EMS MOUTH TO MASK RESUSCITATORS
K983919 · Engineered Medical Systems · Apr 1999
EXHALATION VALVE
K984481 · Intersurgical, Inc. · Jan 1999
EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
K980725 · Instrumentation Industries, Inc. · Aug 1998