FDA product code · Cardiovascular
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Product code MWI covers Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II device regulated under 21 CFR 870.2300. FDA has cleared 306 devices in this code, 4 of them in the last 12 months. Median review time across the 306 most recent decisions is 115 days. openFDA lists 77 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.2300
- Review panel
- Cardiovascular
- Clearances
- 306
What is happening in MWI right now?
MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)) has three findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2878-2026, Z-1557-2026, Z-1144-2026). 2 first-time filers in the last 12 months, Cosinuss GmbH and Baxter Healthcare Corp/ Excel Medical (K253436, K250135). The code is crowded, scoring 78 of 100 — 127 companies hold a clearance here and 4 arrived in the last 12 months (MWI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2878-2026, Z-1557-2026, Z-1144-2026 |
| New entrant | Worth knowing | K253436, K250135 |
| Crowding | Context | MWI:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in MWI?
FDA has cleared 306 devices under product code MWI since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | |
| K253436 | c-med0 alpha | Cosinuss GmbH | |
| K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | |
| K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | |
| K243146 | iCare APP | Ihealth Labs, Inc. | |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices | |
| K233446 | AMC Health CareConsole | Amc Health |
How long does FDA review take for MWI?
The median FDA review time for MWI is 115 days, measured across the 306 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in MWI?
openFDA lists 77 recall records against product code MWI. A recall record covers one firm's corrective action and may span many device lots.
Z-2878-2026Open, ClassifiedGE Medical Systems Information Technologies, Inc.
Portrait Core Services Software version V1.2.0 Security Vulnerability
Z-1557-2026Open, ClassifiedCovidien
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Z-1144-2026Open, ClassifiedEdan Diagnostics
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Z-2071-2025Open, ClassifiedCHANGE HEALTHCARE CANADA COMPANY
Due to complaints, software update may cause software to unexpectedly shutdown.
Z-2072-2025Open, ClassifiedCHANGE HEALTHCARE CANADA COMPANY
Due to complaints, software update may cause software to unexpectedly shutdown.
Showing the 5 most recently initiated of 77. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for MWI?
MAUDE holds 540 adverse-event reports naming product code MWI, 199 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in MWI unusual?
One month sits above MWI's own expected range: 1 October 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 10 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 43 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 7 | 4–18 | Within expected (4–18) | |
| 8 | 3–14 | Within expected (3–14) | |
| 7 | 4–15 | Within expected (4–15) | |
| 10 | 3–15 | Within expected (3–15) | |
| 2 | 3–14 | Below expected (3–14) | |
| 11 | 0–14 | Within expected (0–14) | |
| 16 | 2–24 | Within expected (2–24) | |
| 12 | 2–18 | Within expected (2–18) | |
| 14 | 3–20 | Within expected (3–20) | |
| 54 | 4–20 | Above expected (4–20) | |
| 18 | 0–45 | Within expected (0–45) | |
| 23 | 0–49 | Within expected (0–49) | |
| 17 | 0–57 | Within expected (0–57) | |
| 18 | 0–45 | Within expected (0–45) | |
| 46 | 0–49 | Within expected (0–49) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in MWI.
Who has entered MWI in the last year?
2 companies filed in MWI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Cosinuss GmbH | K253436 | |
| Baxter Healthcare Corp/ Excel Medical | K250135 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in MWI?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in MWI?
Across the 306 most recent decisions, these applicants filed most often in MWI.
| Applicant | Recent clearances |
|---|---|
| Larsen & Toubro Limited | 15 |
| Masimo Corporation | 12 |
| Welch Allyn, Inc. | 12 |
| Agilent Technologies, Inc. | 11 |
| Airstrip Technologies, LP | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in MWI files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| GE Medical Systems Information Technologies, Inc. | 12 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch MWI
Get an email the morning anything changes in MWI — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Cardiovascular
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.