Cleared Traditional

K070411 - AMSURE NEBULIZER

K070411 is an FDA 510(k) clearance for AMSURE NEBULIZER, manufactured by Amsino International, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K070411 · Amsino International, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
231d
Days
Class 2
Risk

K070411 is an FDA 510(k) clearance for the AMSURE NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on October 1, 2007 after a review of 231 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 - K070411

510(k) Number K070411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2007
Decision Date October 01, 2007
Days to Decision 231 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 140d · This submission: 231d
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 441
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K070411.
MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
K072670 · Pari Innovative Manufacturers, Inc. · Dec 2007
FUNHALER, MODEL V-201E
K072822 · Infamed , Ltd. · Nov 2007
AKITA2 APIXNEB
K072019 · Activaero America, Inc. · Nov 2007
OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
K072418 · Respironics New Jersey, Inc. · Sep 2007
AIRLIFE NEBULIZER CAP
K072119 · Cardinalhealth · Aug 2007
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
K062484 · Flaem Nuova S.P.A. · Jun 2007