Loss of Pulse Detection

K242967

Fitbit · cleared 2025-02-25 · product code SDY · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Loss of Pulse Detection is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse data to identify loss of pulse events and provide audio, visual, and haptic alerts to the user.”
Algorithmconvolutional neural network
source quote (p.10)
“The algorithm includes a machine learning component that consists of a convolutional neural network, which analyzes data from photoplethysmography (PPG) and accelerometer sensors.”
Adaptive (vs locked)No
source quote (p.10)
“When algorithm development was complete, the algorithm was locked and the algorithm was evaluated on the held-out test set.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

Retrospective clinical

n=135 patients

endpoints: ability to detect loss of pulse events; ability to initiate an emergency call

Reported performance (2 observations)

sensitivity0.645CI 95% CI: 55.7% to 74.2%
source quote (p.12)
“across 135 users and a sensitivity of 64.5% (95% CI: 55.7% to 74.2%) after adjusting for performance after a simulated collapse.”
specificity0.99965CI 95% CI 99.804, 99.999
source quote (p.12)
“The specificity was analyzed using evaluable data from 131 participants from the first study. It showed a day-level specificity of 99.965% (95% CI 99.804, 99.999).”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
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/K242967