Chrysalis Intelligence · Sponsors · Kestra Medical Technologies, Inc.

Kestra Medical Technologies, Inc.

Kirkland, WA, US · 1 510(k) clearances · 19 PMAs

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Total clearances

1

2024-05-07 → 2024-05-07

Last 12 months

0

Product codes

1

Most recent

2024-05-07

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Class II	Cardiovascular	1	2024-05-07

Class III

PMA approvals (19)

Total PMA records

19

Originals + supplements

Distinct product codes

1

First decision

2021-07-27

Most recent

2026-07-16

Date	PMA #	Trade name	Type	Code	Device name	Specialty
2026-07-16	P200037-S020	ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)	30-Day Notice	MVK	—	—
2026-04-14	P200037-S019	ASSURE Wearable Cardioverter Defibrillator (WCD) System	30-Day Notice	MVK	—	—
2026-03-06	P200037-S018	ASSURE Wearable Cardioverter Defibrillator (WCD) System	Normal 180 Day Track	MVK	—	—
2025-07-22	P200037-S017	ASSURE Wearable Cardioverter Defibrillator (WCD) System	30-Day Notice	MVK	—	—
2025-04-25	P200037-S016	ASSURE Wearable Cardioverter Defibrillator (WCD) System	30-Day Notice	MVK	—	—
2024-10-08	P200037-S014	ASSURE Wearable Cardioverter Defibrillator (WCD) System	30-Day Notice	MVK	—	—
2024-09-03	P200037-S013	ASSURE Wearable Cardioverter Defibrillator (WCD) System	30-Day Notice	MVK	—	—
2024-05-14	P200037-S011	ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)	30-Day Notice	MVK	—	—
2023-10-25	P200037-S010	ASSURE Wearable Cardioverter Defibrillator System (ASSURE system)	30-Day Notice	MVK	—	—
2023-08-17	P200037-S009	ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)	30-Day Notice	MVK	—	—
2023-05-25	P200037-S008	ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)	30-Day Notice	MVK	—	—
2023-02-21	P200037-S007	ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)	30-Day Notice	MVK	—	—
2023-01-10	P200037-S006	ASSURE Wearable Cardioverter Defibrillator system (ASSURE system)	30-Day Notice	MVK	—	—
2022-10-27	P200037-S005	ASSURE Wearable Cardioverter Defibrillator (WCD) System	30-Day Notice	MVK	—	—
2022-10-25	P200037-S004	Assure Wearable Cardioverter Defibrillator (WCD) system	Normal 180 Day Track	MVK	—	—
2021-12-17	P200037-S003	ASSURE Wearable Cardioverter Defibrillator (WCD) System	30-Day Notice	MVK	—	—
2021-11-19	P200037-S001	ASSURE Wearable Cardioverter Defibrillator (WCD) System	Real-Time Process	MVK	—	—
2021-11-10	P200037-S002	ASSURE Wearable Cardioverter Defibrillator (WCD) System	30-Day Notice	MVK	—	—
2021-07-27	P200037	ASSURE Wearable Cardioverter Defibrillator (WCD) System	Original	MVK	—	—

Filings

All 510(k) clearances (1)

Date	K-number	Device	Code	Class	Specialty
2024-05-07	K233864	ASSURE Wearable ECG	MWJ	Class II	Cardiovascular