Medical device manufacturer
Masimo Corporation
Masimo Corporation holds 112 FDA 510(k) clearances across 13 product codes. Median elapsed review time is 100 days. openFDA lists 16 recall records naming the company. FDA publishes it under 6 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 112
- Product codes
- 13
- Median review
- 100 days
- Recall records
- 16
How does FDA spell Masimo Corporation?
FDA publishes this company under 6 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| MASIMO CORPORATION | device/registrationlisting | normalised |
| Masimo Corp. | device/510k | normalised |
| Masimo Corporation | device/registrationlisting | normalised |
| Masimo Corporation | device/enforcement | normalised |
| Masimo Corporation | device/510k | normalised |
| Masimo Corporation | device/recall | normalised |
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, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Masimo Corporation file in?
13 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DQA | Oximeter | 77 | 86 days | |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 12 | 228 days | |
| MUD | Oximeter, Tissue Saturation | 6 | 130 days | |
| DPS | Electrocardiograph | 3 | 164 days | |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 3 | 157 days | |
| OLW | Index-Generating Electroencephalograph Software | 3 | 126 days | |
| NLF | Oximeter, Reprocessed | 2 | 134 days | |
| BZQ | Monitor, Breathing Frequency | 1 | 250 days | |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 290 days | |
| FLL | Continuous Measurement Thermometer | 1 | 221 days | |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 56 days | |
| OLK | Pulse Oximeter For Over-The-Counter Use | 1 | 762 days | |
| QYU | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use | 1 | 135 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Masimo Corporation had a recall?
openFDA lists 16 recall records naming this company across its whole history, of which 2 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-2670-2026Class IIOpen, ClassifiedMHX
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Z-2671-2026Class IIOpen, ClassifiedMHX
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
Z-1536-2024Class IIOpen, ClassifiedDQA
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Z-1537-2024Class IIOpen, ClassifiedDQA
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Z-1538-2024Class IIOpen, ClassifiedDQA
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Showing the 5 most recently initiated of 16.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Masimo Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K260880 | SedLine Sedation Monitor | OLW | 115 | |
| K254209 | Radius VSM and Accessories | MHX | 157 | |
| K243324 | Masimo O3 Regional Oximeter | MUD | 267 | |
| K250757 | Radius VSM and Accessories | MHX | 78 | |
| K243305 | Masimo W1 | DPS | 164 | |
| K240229 | Masimo W1 | DPS | 192 | |
| K234021 | Masimo Stork | QYU | 135 | |
| K214115 | MightySat -OTC | OLK | 762 | |
| K223721 | Masimo Stork | DQA | 368 | |
| K232512 | Masimo W1 | DPS | 91 |
Source: openFDA device/510k · retrieved
Where is Masimo Corporation registered?
FDA lists 4 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Masimo Corporation files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
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.