510(k) Report

FDA applicant

Airstrip Technologies, LP

San Antonio, TX15 decisions2009–20211 recall

FDA records 15 decisions for Airstrip Technologies, LP (San Antonio, TX) from 2009 to 2021: 15 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and MSX (System, Network And Communication…). Since 2016 its 510(k)s took a median of 169 days from receipt to decision, against 217 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Airstrip Technologies, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Airstrip Technologies, LP’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2009: 22010: 12011: 22012: 32013: 12014: 22015: 12016: 12018: 12021: 1
2009high 3 (2012) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2009high 1 (2016) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Airstrip Technologies, LP by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Airstrip Technologies, LP’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)9decisions
  • MSXSystem, Network And Communication, Physiological Monitors3decisions
  • HGMSystem, Monitoring, Perinatal2decisions
  • LQKHome Uterine Activity Monitor1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 169 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 217 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K122133Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingAirstrip Technologies, LP · 20124cite it
  • K143114Sense4Baby System Model B+ (MSA)Airstrip Technologies, Inc. · 20153cite it
  • K160862AirStrip RPMAirstrip Technologies, Inc. · 20163cite it
  • K133450Airstrip Remote Patient MonitoringAirstrip Technologies, LP · 20143cite it
  • K090269Airstrip OBAirstrip Technologies, LP · 20091cites it
  • K100133Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing Software, Version 3.1Airstrip Technologies, LP · 20101cites it

What has FDA decided for it lately?

  • K211949AirStrip ONE Web Client with Alarm Communication Management (ACM)Airstrip Technologies, Inc. · 2021
  • K182226AirStrip RPM InvisionHeart AdapterAirstrip Technologies, Inc. · 2018
  • K160862AirStrip RPMAirstrip Technologies, Inc. · 2016
  • K143114Sense4Baby System Model B+ (MSA)Airstrip Technologies, Inc. · 20151 recall
  • K133450Airstrip Remote Patient MonitoringAirstrip Technologies, LP · 2014
  • K133394Airstrip Remote Patient MonitoringAirstrip Technologies, LP · 2014
  • K131786Airstrip Remote Patient Monitoring Philips AdapterAirstrip Technologies, LP · 2013
  • K121712Airstrip RPM for Lifenet ConsultAirstrip Technologies, Inc. · 2012

All 10 as Airstrip Technologies, LP →All 5 as Airstrip Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K143114AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated…Aug 4, 2016Class II