Data / Medical devices / United States / Analog Devices
Analog Devices: FDA-registered device maker in Wilmington, MA, United States, 3 510(k) clearances
Analog Devices is registered with the FDA (registration 3000130829) in Wilmington, MA, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 16, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3000130829
- Address
- One Analog Way, Wilmington, MA, United States, 01887
- Owner or operator
- Analog Devices (10089993)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 30, 2024
- Registered through
- 2027
- Brand names listed
- Sensinel CPM Adhesives, Sensinel CPM Adhesives Gen 1.6, Sensinel CPM Adhesives Gen 2, Sensinel CPM Base Station, Sensinel CPM Base Station Gen 1.6, Sensinel CPM Base Station Gen 2, Sensinel CPM Intelligent Algorithm Gen 1.6, Sensinel CPM Mobile Application and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Plethysmograph, Impedance | DSB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stethoscope, Electronic | DQD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2026 | K260801 | Sensinel Cardiopulmonary Management (CPM) System | MWI | Substantially Equivalent | Analog Devices | accessdata.fda.gov |
| December 10, 2024 | K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | MWI | Substantially Equivalent | Analog Devices | accessdata.fda.gov |
| December 22, 2023 | K231086 | CPM System | MWI | Substantially Equivalent | Analog Devices, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Plethysmograph, Impedance
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Stethoscope, Electronic
- All makers of Continuous Measurement Thermometer
- All makers of Electrocardiograph
- All makers of Monitor, Breathing Frequency
Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.