FDA product code · Cardiovascular · Class 2
MSX: System, Network And Communication, Physiological Monitors
MSX is FDA's product code for "System, Network And Communication, Physiological Monitors": a Class 2 device classified under 21 CFR 870.2300, reviewed by the Cardiovascular panel. FDA flags it as life-sustaining or life-supporting.
510(k) review time for MSX
Across 36 510(k) clearances under MSX decided from 2018-01-01 to 2026-10-06, the median was 188 days from FDA receipt to decision. Half took between 113 and 235 days, and 80% were decided within 266 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 113 |
| Median | 188 |
| 75th percentile | 235 |
| 80th percentile | 266 |
| 90th percentile | 338 |
| Slowest | 547 |
| Year | Median days | n |
|---|---|---|
| 2020 | 193 | 5 |
| 2022 | 177 | 5 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MSX in the public FDA record
| 510(k) clearances, all years | 119 |
|---|---|
| Device recalls | 21 |
| Establishment listings | 196 |
Counts of records, not of devices or events. Adverse event reports for MSX are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MSX
6 FDA recognized consensus standards cite MSX, 1 of them recognized only in part, among them ANSI AAMI 2700-1:2019; IEEE Std 11073-10406-2023; IEEE Std 11073-10406-2011. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 13-120 ANSI AAMI 2700-1:2019 — Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
- 13-147 IEEE Std 11073-10406-2023 — Health informatics - Device Interoperability Part 10406: Personal health device communication - Device Specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
- 13-56 IEEE Std 11073-10406-2011 — Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
- 13-75 ISO IEEE 11073-10102 First edition 2014-03-01 — Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
- 13-76 ISO 11073-91064 First edition 2009-05-01 — Health informatics - Standard communication protocol - Computer-assisted electrocardiography
- 3-203 IEC 80601-2-49 Edition 1.1 2024-09 CONSOLIDATED VERSION (partial recognition) — Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.