ASSURE Wearable ECG

K233864

Kestra Medical Technologies, Inc. · cleared 2024-05-07 · product code MWJ · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The ASSURE Wearable ECG is a reusable, ambulatory electrocardiography-based, cardiac- and physiologic-monitoring, medical-electrical system whose intended purpose is to inform clinical management of options for diagnosing, monitoring and/or mitigating cardiac conditions after patient's improvement following ASSURE® Wearable Cardioverter Defibrillator (WCD) prescriptive use. The system utilizes the same algorithm detection and episode reporting software marketed in the ASSURE WCD with high (Tachy) and low (Brady) capture for later transmission to the medical professional for interpretation.”
Algorithmembedded arrhythmia detection algorithm; proprietary algorithm detection software
source quote (p.7)
“Data is auto-triggered for events such as Bradycardia and Tachycardia, as identified by an embedded arrhythmia detection algorithm; and stored as low and high heart rate episodes and patient-triggered events”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

standards: IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-1-11:2015+A1:2021, IEC 60601-2-47:2015, ISO 10993-1:2018, UL 2054:2004(R2011), IEC 62133-2:2017, AIM 7351731:2017

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

2
recalls in product code, 24mo
6
MAUDE reports in code, 12mo
+38%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K233864