Kestra Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Kestra Medical Technologies, Inc.” (first 2024, latest 2024), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 153 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2024 | 1 | 153 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kestra Medical Technologies, Inc. took a median 153 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 268 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MVK | Wearable Automated External Defibrillator | 1 | 0 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 | 1 |
Review panels
- Cardiovascular (2)
Most recent Kestra Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233864 | ASSURE Wearable ECG | MWJ | 2024-05-07 | 153 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200037 | PMA | ASSURE Wearable Cardioverter Defibrillator (WCD) System | 2021-07-27 |
Recalls
openFDA lists no recalls under a recalling firm named Kestra Medical Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Kestra Medical Technologies, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05135403: ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS) (Recruiting, started 2021-11-20)
- NCT04132466: ASSURE WCD Clinical Evaluation - Conversion Efficacy Study (Completed, started 2019-11-25)
- NCT03887052: ASSURE WCD Clinical Evaluation - Detection and Safety Study (Completed, started 2019-03-20)
SEC filings
KESTRA MEDICAL TECHNOLOGIES, LTD. (KMTS): EDGAR filings, CIK 1877184. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kestra Medical Technologies, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Kestra Medical Technologies, Inc.” (first 2024, latest 2024), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kestra Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kestra Medical Technologies, Inc. is 153 days.
Which FDA product codes appear under Kestra Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are MVK (Wearable Automated External Defibrillator, 1); MWJ (Electrocardiograph, Ambulatory (Without Analysis), 1).
Next steps
- See all 1 Kestra Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MVK, Kestra Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.