Cleared Traditional

K991355 - METERED DOSE INHALER ADAPTER-DISPOSABLE

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

K991355 · Instrumentation Industries, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 132
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K991355.
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
K060811 · Omron Healthcare, Inc. · May 2006
800 SERIES EASYNEB NEBULIZER
K020357 · Nellcor Puritan Bennett, Inc. · Aug 2002
SALTER LABS MODIFIED NEBUTECH NEBULIZER
K014056 · Salter Labs · Feb 2002
SALTER AIRE COMPRESSOR
K992285 · Salter Labs · Jan 2000
MODEL IRC 1001 AEROSOL COMPRESSOR
K992643 · Invacare Corp. · Oct 1999
SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER
K992986 · Salter Labs · Sep 1999