Cleared Traditional

K091111 - RTC METERED DOSE INHALER ADAPTERS-SINGL...

K091111 is the FDA 510(k) clearance for RTC METERED DOSE INHALER ADAPTERS-SINGL... by Instrumentation Industries, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K091111 · Instrumentation Industries, Inc. · Anesthesiology device
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Dec 2009
Decision
229d
Days
Class 2
Risk

K091111 is an FDA 510(k) clearance for the RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI.... 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 December 2, 2009 after a review of 229 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 K091111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2009
Decision Date December 02, 2009
Days to Decision 229 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 140d · This submission: 229d
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 K091111.
U-RIGHT COMPRESSOR NEBULIZER
K121969 · Taidoc Technology Corporation · Feb 2013
COMP A-I-R
K110860 · Omron Healthcare, Inc. · Sep 2011
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
K101857 · Instrumentation Industries, Inc. · Jul 2010
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
K081738 · Health & Life Co., Ltd. · Sep 2008
NEB-U-MASK SYSTEM, MODELS 1895, 1896
K080230 · Teleflexmedical, Inc. · Jun 2008
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
K062263 · Omron Healthcare, Inc. · Feb 2007