Data / Medical devices / United States / KESTRA Medical Technologies, Inc.
KESTRA Medical Technologies, Inc.: FDA-registered device maker in Kirkland, WA, United States, 1 510(k) clearance and 1 PMA approval
KESTRA Medical Technologies, Inc. is registered with the FDA (registration 3015185344) in Kirkland, WA, United States. It lists 5 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated May 7, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015185344
- Address
- 3933 Lake Washington Blvd, NE, Kirkland, WA, United States, 98033
- Owner or operator
- Kestra Medical (10082485)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 3, 2021
- Registered through
- 2027
- Brand names listed
- ASSURE Wearable ECG, ASSURE® CareStation, ASSURE® Wearable Cardioverter Defibrillator (WCD) system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Communication, Powered | ILQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wearable Automated External Defibrillator | MVK | 3 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 7, 2024 | K233864 | ASSURE Wearable ECG | MWJ | Substantially Equivalent | Kestra Medical Technologies, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 27, 2021 | P200037 | ASSURE Wearable Cardioverter Defibrillator (WCD) System | MVK | 19 | September 28, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of System, Communication, Powered
- All makers of Wearable Automated External Defibrillator
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
Updated September 28, 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.