Cleared Special

K133450 - AIRSTRIP REMOTE PATIENT MONITORING

K133450 is an FDA 510(k) clearance for AIRSTRIP REMOTE PATIENT MONITORING, 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 95-day FDA review.

K133450 · Airstrip Technologies, LP · Cardiovascular device
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Feb 2014
Decision
95d
Days
Class 2
Risk

K133450 is an FDA 510(k) clearance for the AIRSTRIP REMOTE PATIENT MONITORING. 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 February 14, 2014 after a review of 95 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133450

510(k) Number K133450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 11, 2013
Decision Date February 14, 2014
Days to Decision 95 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 307
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