FDA product code MSX: System, Network And Communication, Physiological Monitors
MSX is the FDA product code for system, network and communication, physiological monitors. It is a Class II device, regulated under 21 CFR 870.2300 and reviewed by the Cardiovascular panel. FDA has cleared 120 510(k) submissions under MSX, 20 in the last five years, from 65 different applicants. The average 510(k) review took 132 days (median 98); 204 days on average over the last three years. FDA has posted 21 recalls for MSX devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Network And Communication, Physiological Monitors |
| Device class | Class II |
| Regulation | 21 CFR 870.2300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for MSX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 152 |
| 2018 | 4 | 132 |
| 2019 | 4 | 114 |
| 2020 | 5 | 195 |
| 2021 | 3 | 209 |
| 2022 | 5 | 272 |
| 2023 | 3 | 259 |
| 2024 | 4 | 207 |
| 2025 | 4 | 262 |
| 2026 | 4 | 142 |
Compare with all 510(k) review times · Search every MSX clearance
Top MSX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Datex-Ohmeda | 8 | 2004-10-15 |
| Data Critical Corp. | 8 | 2001-10-19 |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 7 | 2025-07-31 |
| Draeger Medical Systems, Inc. | 5 | 2024-07-12 |
| Visicu, Inc. | 5 | 2022-06-03 |
60 more applicants have MSX clearances. See the full list in Caduvo.
Most recent MSX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261287 | Ascom Ums Srl Unipersonale | Digistat Care | 2026-09-12 | 145 |
| K260211 | Hill-Rom, Inc. | Dashboard (P007000) | 2026-08-13 | 202 |
| K261367 | Corsano Health B.V. | Corsano CardioWatch 287-2 System | 2026-07-26 | 90 |
| K253654 | Philips Medizin Systeme Böblingen GmbH | IntelliVue Measurement Rack 6000 (867317) | 2026-03-30 | 130 |
| K243270 | Tigerconnect | TigerConnect Alarm Management | 2025-09-30 | 349 |
Recalls for MSX devices
21 product recalls in 21 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-11-18.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MSX?
MSX is the FDA product code for system, network and communication, physiological monitors. It is a Class II device, regulated under 21 CFR 870.2300 and reviewed by the Cardiovascular panel.
What device class is MSX?
Class II, regulation 21 CFR 870.2300. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSX?
Across 120 cleared submissions the average was 132 days from receipt to decision (median 98).
Which companies have the most MSX clearances?
Datex-Ohmeda (8); Data Critical Corp. (8); Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (7); Draeger Medical Systems, Inc. (5); Visicu, Inc. (5).
Have MSX devices been recalled?
Yes: 21 product recalls across 21 recall events; the most recent began 2025-11-18.
Next steps
- Run an FDA pathway report with predicate devices for product code MSX
- Run a recall and safety report across every MSX manufacturer
- Watch product code MSX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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