Cleared Special

K110503 - AIRSTRIP REMOTE PATIENT MONITORING (RPM)

K110503 is an FDA 510(k) clearance for AIRSTRIP REMOTE PATIENT MONITORING (RPM), manufactured by Airstrip Technologies, LP. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 16-day FDA review.

K110503 · Airstrip Technologies, LP · Cardiovascular device
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Mar 2011
Decision
16d
Days
Class 2
Risk

K110503 is an FDA 510(k) clearance for the AIRSTRIP REMOTE PATIENT MONITORING (RPM). Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Airstrip Technologies, LP (San Antonio, US). The FDA issued a Cleared decision on March 10, 2011 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight 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 Airstrip Technologies, LP devices

FDA 510(k) Submission Details - K110503

510(k) Number K110503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2011
Decision Date March 10, 2011
Days to Decision 16 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 175
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