Cleared Traditional

K091862 - NESSI SPACER

K091862 is an FDA 510(k) clearance for NESSI SPACER, manufactured by Pharmacaribe. The device is a Class 2 Anesthesiology device with product code NVO cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K091862 · Pharmacaribe · Anesthesiology device
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Nov 2009
Decision
150d
Days
Class 2
Risk

K091862 is an FDA 510(k) clearance for the NESSI SPACER. Classified as Spacer, Direct Patient Interface (product code NVO), Class II - Special Controls.

Submitted by Pharmacaribe (Bonita Springs, US). The FDA issued a Cleared decision on November 20, 2009 after a review of 150 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.

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FDA 510(k) Submission Details - K091862

510(k) Number K091862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date November 20, 2009
Days to Decision 150 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 140d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NVO Device Classification - Class 2, Special Controls

Product Code NVO Spacer, Direct Patient Interface
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
Definition Spacers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers That Are Comprised Of A Reservior Into Which An Aerosol Medication Is Dispensed. A Spacer Uses An Open Mouthpiece. Spacers Are Intended To Minimize Delivery Of Large Aerosolized Particles.
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.