Cleared Traditional

K991355 - METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE

K991355 is an FDA 510(k) clearance for METERED DOSE INHALER ADAPTER-DISPOSABLE, manufactured by Instrumentation Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K991355 · Instrumentation Industries, Inc. · Anesthesiology device
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Jan 2000
Decision
283d
Days
Class 2
Risk

K991355 is an FDA 510(k) clearance for the METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 283 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 - K991355

510(k) Number K991355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date January 27, 2000
Days to Decision 283 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
143d slower than avg
Panel avg: 140d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 338
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K991355.
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER
K993199 · Ferraris Medical, Inc. · Mar 2000
SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896
K994352 · Hudson Respiratory Care, Inc. · Mar 2000
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER
K990897 · Puritan-Bennett Ireland, Ltd. · Mar 2000
SALTER AIRE COMPRESSOR
K992285 · Salter Labs · Jan 2000
EZFLOW MAX, MODEL 1007
K993558 · Piper Medical Products · Nov 1999
PRIMEAIRE
K992722 · Thayer Medical Corp. · Nov 1999