Cleared Traditional

K240499 - ARTAIRA Arterial Compression Device (AA...

K240499 is an FDA 510(k) clearance for ARTAIRA Arterial Compression Device (AA..., manufactured by Airos Medical, Inc.. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K240499 · Airos Medical, Inc. · Cardiovascular device
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Oct 2024
Decision
234d
Days
Class 2
Risk

K240499 is an FDA 510(k) clearance for the ARTAIRA Arterial Compression Device (AACD01). Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Airos Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on October 11, 2024 after a review of 234 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Airos Medical, Inc. devices

FDA 510(k) Submission Details - K240499

510(k) Number K240499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2024
Decision Date October 11, 2024
Days to Decision 234 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 125d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 120
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K240499.
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