Cleared Traditional

K121609 - ASTHMAPOLIS SYSTEM

K121609 is the FDA 510(k) clearance for ASTHMAPOLIS SYSTEM by Reciprocal Labs Corporation. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K121609 · Reciprocal Labs Corporation · Anesthesiology device
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Jul 2012
Decision
31d
Days
Class 2
Risk

K121609 is an FDA 510(k) clearance for the ASTHMAPOLIS SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Reciprocal Labs Corporation (Madison, US). The FDA issued a Cleared decision on July 2, 2012 after a review of 31 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Reciprocal Labs Corporation devices

Submission Details

510(k) Number K121609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date July 02, 2012
Days to Decision 31 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 140d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 135
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