MSXClass II
System, Network And Communication, Physiological Monitors
21 CFR 870.2300 / Cardiovascular
MSX is the FDA product code for System, Network And Communication, Physiological Monitors, a class II device type, regulated under 21 CFR 870.2300. As of , FDA records hold 119 510(k) clearances under this code, the most recent dated , and 21 recalls.
Classification record
- Product code
- MSX
- Device name
- System, Network And Communication, Physiological Monitors
- Regulation
- 21 CFR 870.2300
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 120
- Ingested recalls
- 21
Clearances, product code MSX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1997 | 5 |
| 1998 | 6 |
| 1999 | 2 |
| 2000 | 4 |
| 2001 | 8 |
| 2002 | 6 |
| 2003 | 5 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 7 |
| 2007 | 4 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 7 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 5 |
| 2016 | 3 |
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 4 |
| 2020 | 5 |
| 2021 | 3 |
| 2022 | 5 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 4 |
| 2026 | 4 |
Applicants with the most clearances
Product code MSX| Applicant | Clearances |
|---|---|
| GE Healthcare | 16 |
| Data Critical Corp. | 9 |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | 7 |
| Philips North America LLC | 6 |
| Current Health Inc | 5 |
| Draeger Medical Systems, Inc. | 5 |
| Visicu, Inc. | 5 |
| Earlysense, Ltd. | 4 |
| AirStrip Technologies, Inc. | 3 |
| Cardiopulmonary Corp. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this code- ActiGraph L.L.C.
- AirStrip Technologies, Inc.
- Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.
- Amphenol Medical Technologies (Dongguan) Co., Ltd.
- Ascom (US) Inc.
- Ascom Sweden AB
- Ascom Ums SRL
- Athena GTX
- Baxter Innovations & Business Solutions Pvt. Ltd.
- Cerner Corporation
- Corsano Health B.V.
- Creative Foam Corporation dba MT. OLIVE Mfg
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
