Masimo Corporation: FDA clearances and approvals
Masimo Corporation has 113 FDA 510(k) clearances (first 1997, latest 2026), plus 2 De Novo decisions, across 15 product codes in 5 review panels. Median 510(k) review time: 102 days. Since 2017 its median was 192 days, against 206 days for all cleared 510(k)s in the same product codes. openFDA lists 16 product recalls by a recalling firm named Masimo Corporation. It is the industry lead sponsor of 85 device clinical trials on ClinicalTrials.gov. It files with the SEC as MASIMO CORP (MASI).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 74 |
| 2013 | 1 | 389 |
| 2014 | 2 | 121 |
| 2015 | 1 | 255 |
| 2016 | 5 | 228 |
| 2017 | 3 | 238 |
| 2018 | 3 | 250 |
| 2019 | 5 | 184 |
| 2020 | 5 | 94 |
| 2021 | 3 | 221 |
| 2022 | 3 | 130 |
| 2023 | 6 | 280 |
| 2024 | 3 | 192 |
| 2025 | 3 | 164 |
| 2026 | 3 | 157 |
Review time against the same product codes
Since 2017, Masimo Corporation's cleared 510(k)s took a median 192 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 206 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQA | Oximeter | 77 | 77 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 13 | 13 |
| MUD | Oximeter, Tissue Saturation | 6 | 6 |
| DPS | Electrocardiograph | 3 | 3 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 3 | 3 |
| OLW | Index-Generating Electroencephalograph Software | 3 | 3 |
| NLF | Oximeter, Reprocessed | 2 | 2 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Plus 5 more product codes.
Review panels
- Anesthesiology (84)
- Cardiovascular (21)
- General and Plastic Surgery (6)
- Neurology (3)
- General Hospital (1)
Most recent Masimo Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253417 | Masimo Root Monitoring System | MWI | 2026-08-12 | 315 |
| K260880 | SedLine Sedation Monitor | OLW | 2026-07-10 | 115 |
| K254209 | Radius VSM and Accessories | MHX | 2026-06-04 | 157 |
| K243324 | Masimo O3 Regional Oximeter | MUD | 2025-07-17 | 267 |
| K250757 | Radius VSM and Accessories | MHX | 2025-05-29 | 78 |
| K243305 | Masimo W1 | DPS | 2025-04-03 | 164 |
| K240229 | Masimo W1 | DPS | 2024-08-08 | 192 |
| K234021 | Masimo Stork | QYU | 2024-05-03 | 135 |
| K214115 | MightySat -OTC | OLK | 2024-01-31 | 762 |
| K223721 | Masimo Stork | DQA | 2023-12-15 | 368 |
103 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200076 | De Novo | Hyperoxia Monitoring Device Adjunct To Pulse Oximetry | 2023-10-12 |
| DEN200011 | De Novo | Monitor For Opioid Induced Impairment Of Oxygenation | 2023-03-31 |
Recalls
16 product recalls in 9 recall events; 10 initiated in the last five years. Most recent: 2026-02-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Masimo Corporation is the industry lead sponsor of 85 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT07223177: Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations (Recruiting, started 2025-12-17)
- NCT07223164: Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease (Recruiting, started 2025-10-21)
- NCT06334055: Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073 (Completed, started 2024-03-04)
- NCT06432881: Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE) (Recruiting, started 2024-01-08)
- NCT06148623: Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation (Completed, started 2023-11-13)
SEC filings
MASIMO CORP (MASI): EDGAR filings, CIK 937556. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Masimo Corporation have?
Masimo Corporation has 113 FDA 510(k) clearances (first 1997, latest 2026), plus 2 De Novo decisions, across 15 product codes in 5 review panels.
How long does FDA take to clear Masimo Corporation's 510(k)s?
The median time from FDA receipt to decision across Masimo Corporation's cleared 510(k)s is 102 days. Since 2017: 192 days, versus 206 days for all cleared 510(k)s in the same product codes.
What devices does Masimo Corporation make?
Its most frequent FDA product codes are DQA (Oximeter, 77); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 13); MUD (Oximeter, Tissue Saturation, 6).
Has Masimo Corporation had device recalls?
openFDA lists 16 product recalls in 9 recall events by a recalling firm whose name matches Masimo Corporation; the most recent began 2026-02-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 113 Masimo Corporation clearances with predicates and recalls
- Run predicate analysis for product code DQA, Masimo Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.