Cleared Traditional

K102719 - ATLANTEAN TRIGGER NEBULIZER

K102719 is an FDA 510(k) clearance for ATLANTEAN TRIGGER NEBULIZER, manufactured by Atlantean Corporation. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K102719 · Atlantean Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
283d
Days
Class 2
Risk

K102719 is an FDA 510(k) clearance for the ATLANTEAN TRIGGER NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Atlantean Corporation (Temecula, US). The FDA issued a Cleared decision on July 1, 2011 after a review of 283 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.

FDA 510(k) Submission Details - K102719

510(k) Number K102719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2010
Decision Date July 01, 2011
Days to Decision 283 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
143d slower than avg
Panel avg: 140d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - CAF Nebulizer (direct Patient Interface)

All 442
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K102719.
I-NEB AAD SYSTEM WITH TIM
K102454 · Respironics Respiratory Drug Delivery (Uk) , Ltd. · Oct 2011
MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR
K111570 · Thayer Medical Corporation · Sep 2011
COMP A-I-R
K110860 · Omron Healthcare, Inc. · Sep 2011
AEROVENT PLUS CHC
K110273 · Monaghan Medical Corporation · Jun 2011
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085
K103635 · Aerogen, Ltd. · May 2011
FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001
K101552 · Foshan Care Medical Technology Co., Ltd. · Mar 2011