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AirStrip Technologies, Inc.: FDA-registered device maker in San Antonio, TX, United States, 9 510(k) clearances

Name: AirStrip Technologies, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

AirStrip Technologies, Inc. is registered with the FDA (registration 3006104191) in San Antonio, TX, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 14, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006104191
Address: 2915 W Bitters Rd. Suite 215, San Antonio, TX, United States, 78248
Owner or operator: AirStrip Technologies (9065519)
Roles: Manufacturer
First device listed: September 1, 2011
Registered through: 2026
Brand names listed: AIRSTRIP PATIENT MONITORING, AirStrip AHI, AirStrip Alarm Communication Management, AirStrip Cardiology, AirStrip InsightIQ, AirStrip OB, AirStrip ONE Web client

Devices it lists

Device	Product code	Class	Role	Source
Adjunctive Hemodynamic Indicator With Decision Point	QNV	2	Manufacturer	accessdata.fda.gov
Medium-Term Adjunctive Predictive Cardiovascular Indicator	QNL	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Manufacturer	accessdata.fda.gov
System, Monitoring, Perinatal	HGM	2	Manufacturer	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 14, 2022	K221203	AHI System	QNV	Substantially Equivalent	Fifth Eye, Inc.	accessdata.fda.gov
December 9, 2021	K211949	AirStrip ONE Web Client with Alarm Communication Management (ACM)	MSX	Substantially Equivalent	Airstrip Technologies, Inc.	accessdata.fda.gov
December 3, 2021	K212219	AHI System	QNV	Substantially Equivalent	Fifth Eye, Inc.	accessdata.fda.gov
March 1, 2021	DEN200022	Analytic for Hemodynamic Instability (AHI)	QNV	Unknown	Fifth Eye, Inc.	accessdata.fda.gov
September 19, 2016	K160862	AirStrip RPM	MSX	Substantially Equivalent	Airstrip Technologies, Inc.	accessdata.fda.gov
January 18, 2015	K142106	DECISIO HEALTH PATIENT DASHBOARD	MWI	Substantially Equivalent	Decisio Health, Inc.	accessdata.fda.gov
February 14, 2014	K133450	AIRSTRIP REMOTE PATIENT MONITORING	MWI	Substantially Equivalent	Airstrip Technologies, LP	accessdata.fda.gov
August 26, 2011	K112235	AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING	MWI	Substantially Equivalent	Airstrip Technologies, LP	accessdata.fda.gov
February 13, 2009	K090269	AIRSTRIP OB	HGM	Substantially Equivalent	Airstrip Technologies, LP	accessdata.fda.gov

Compare with other makers

Updated July 14, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.