Cleared Traditional

K101532 - NESSI OTC SPACER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101532 · Pharmacaribe · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
90d
Days
Class 2
Risk

K101532 is an FDA 510(k) clearance for the NESSI OTC 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 September 1, 2010 after a review of 90 days - within the typical 510(k) review window.

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 Pharmacaribe devices

Submission Details

510(k) Number K101532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2010
Decision Date September 01, 2010
Days to Decision 90 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
49d faster than avg
Panel avg: 139d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.