Cleared Traditional

K133394 - AIRSTRIP REMOTE PATIENT MONITORING

K133394 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 Traditional 510(k) pathway after a 93-day FDA review.

K133394 · Airstrip Technologies, LP · Cardiovascular device
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Feb 2014
Decision
93d
Days
Class 2
Risk

K133394 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 6, 2014 after a review of 93 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. 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.

FDA 510(k) Submission Details - K133394

510(k) Number K133394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2013
Decision Date February 06, 2014
Days to Decision 93 days
Submission Type Traditional
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
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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

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
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K133394.
OMNI PATENT MONITORS
K132229 · Infinium Medical · Feb 2014
A SERIES AND Q SERIES PATIENT MONITORS
K131898 · Guangdong Biolight Meditech Co., Ltd. · Feb 2014
AIRSTRIP REMOTE PATIENT MONITORING
K133450 · Airstrip Technologies, LP · Feb 2014
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
K132807 · Welch Allyn, Inc. · Jan 2014
VISI MOBILE MONITIORING SYSTEM
K133586 · Sotera Wireless, Inc. · Dec 2013
MCKESSON CARDIOLOGY HEMO
K131497 · Mckesson Israel , Ltd. · Dec 2013