Cleared Traditional

K160862 - AirStrip RPM

K160862 is an FDA 510(k) clearance for AirStrip RPM, manufactured by Airstrip Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K160862 · Airstrip Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
174d
Days
Class 2
Risk

K160862 is an FDA 510(k) clearance for the AirStrip RPM. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Airstrip Technologies, Inc. (San Antonio, US). The FDA issued a Cleared decision on September 19, 2016 after a review of 174 days - an extended review cycle.

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.

View all Airstrip Technologies, Inc. devices

FDA 510(k) Submission Details - K160862

510(k) Number K160862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2016
Decision Date September 19, 2016
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
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 - MSX System, Network And Communication, Physiological Monitors

All 74
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K160862.
Unite Connect for Clinical Systems
K180566 · Ascom (Sweden) AB · Apr 2018
Athena GTX Device Management Suite (ADMS) Software
K173203 · Athena Gtx · Mar 2018
BeneVision Central Monitoring System
K162607 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2017
CareEvent inclusive of the CareEvent Mobile Application accessory
K161164 · Philips Medical Systems · Jun 2016
Hypervisor IX Monitoring System
K150632 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2015
CareEvent
K142935 · Philips Medical Systems · Jan 2015