Cleared Traditional

K121609 - ASTHMAPOLIS SYSTEM

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

K121609 · Reciprocal Labs Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K121609

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
Combination Product No
PCCP Authorized No
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.

CAF Device Classification - Class 2, Special Controls

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 349
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K121609.
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
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ULTRASONIC NEBULIZER
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SPIRALE DRUG DELIVERY SYSTEM
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QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER
K112824 · Quality Life Technologies Co;Ltd · Jun 2012
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML
K113033 · Nephron Pharmaceuticals Corp. · Jun 2012
ERAPID NEBULIZER SYSTEM
K112859 · Pari Respiratory Equipment, Inc. · May 2012