Cleared Traditional

K984481 - EXHALATION VALVE

K984481 is an FDA 510(k) clearance for EXHALATION VALVE, manufactured by Intersurgical, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K984481 · Intersurgical, Inc. · Anesthesiology device
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Jan 1999
Decision
44d
Days
Class 2
Risk

K984481 is an FDA 510(k) clearance for the EXHALATION VALVE. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Intersurgical, Inc. (Liverpool, US). The FDA issued a Cleared decision on January 29, 1999 after a review of 44 days - a notably fast clearance 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: 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 Intersurgical, Inc. devices

FDA 510(k) Submission Details - K984481

510(k) Number K984481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1998
Decision Date January 29, 1999
Days to Decision 44 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 140d · This submission: 44d
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 36
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K984481.
RUSCH EMERGENCY MASK
K993528 · Rusch, Inc. · May 2000
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
K983631 · Instrumentation Industries, Inc. · Jul 1999
EMS MOUTH TO MASK RESUSCITATORS
K983919 · Engineered Medical Systems · Apr 1999
EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
K980725 · Instrumentation Industries, Inc. · Aug 1998
NON-REBREATHING 'T' (BE 117)
K973066 · Instrumentation Industries, Inc. · Feb 1998
ONE-WAY VALVE (WITH CONNECTOR)
K970780 · Instrumentation Industries, Inc. · Sep 1997