Cleared Special

K101857 - RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101857 · Instrumentation Industries, Inc. · Anesthesiology device
Jul 2010
Decision
20d
Days
Class 2
Risk

K101857 is an FDA 510(k) clearance for the RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V. 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 July 22, 2010 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K101857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2010
Decision Date July 22, 2010
Days to Decision 20 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
205d faster than avg
Panel avg: 225d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 10
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K101857.
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