Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing
FDA 510(k) K122133 · Airstrip Technologies, LP
510(k) numberK122133
Submission
- Device name
- Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing
- Applicant
- Airstrip Technologies, LP
San Antonio, TX, US - Received
- July 18, 2012
- Decision date
- October 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
Other 510(k)s with product code MWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2)MWI · Traditional | Infinium Medical, Inc. | 08/14/2026SE |
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | Masimo Corporation | 08/12/2026SE |
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)MWI · Traditional | Midmark Corporation | 06/12/2026SE |
| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)MWI · Traditional | Fysicon BV | 08/27/2025SE |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalMWI · Traditional | Empatica S.r.l. | 06/06/2025SE |
| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
More from Welch Allyn, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM)MSX · Special | 12/09/2021SE |
| K182226 | AirStrip RPM InvisionHeart AdapterMWI · Traditional | 09/11/2018SE |
| K160862 | AirStrip RPMMSX · Traditional | 09/19/2016SE |
| K143114 | Sense4Baby System Model B+ (MSA)LQK · Traditional | 03/10/2015SE |
| K133450 | Airstrip Remote Patient MonitoringMWI · Special | 02/14/2014SE |
| K133394 | Airstrip Remote Patient MonitoringMWI · Traditional | 02/06/2014SE |
| K131786 | Airstrip Remote Patient Monitoring Philips AdapterMWI · Traditional | 07/03/2013SE |
| K121712 | Airstrip RPM for Lifenet ConsultMSX · Traditional | 11/20/2012SE |
| K121871 | Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingMWI · Traditional | 07/03/2012SE |
| K112235 | Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingMWI · Traditional | 08/26/2011SE |
Questions and answers
When was Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing cleared by the FDA?
Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing (K122133) received a 510(k) decision of Substantially Equivalent on October 2, 2012, 76 days after the submission was received.
What is the product code of K122133?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.