Cleared Special

K070990 - APEX MEDICAL MOBINEB, 9R-027 SERIES

K070990 is an FDA 510(k) clearance for APEX MEDICAL MOBINEB, manufactured by Apex Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 39-day FDA review.

K070990 · Apex Medical Corp. · Anesthesiology device
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May 2007
Decision
39d
Days
Class 2
Risk

K070990 is an FDA 510(k) clearance for the APEX MEDICAL MOBINEB, 9R-027 SERIES. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Apex Medical Corp. (Taipei County, TW). The FDA issued a Cleared decision on May 18, 2007 after a review of 39 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Apex Medical Corp. devices

FDA 510(k) Submission Details - K070990

510(k) Number K070990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2007
Decision Date May 18, 2007
Days to Decision 39 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 140d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

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 377
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