Loop System

K181352

Spry Health, Inc. · cleared 2019-03-29 · product code DQA · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Loop System is a prescription-only medical device indicated for use by adult patients in the home environment for passive, non-invasive, intermittent data collection of resting (i.e., no motion) physiological parameters. The data is derived from reflectance-based photoplethysmogram (PPG) signals from the patient's wrist, collected by Light Emitting Diodes (LEDs) of varying wavelengths and photodiodes sensitive to said wavelengths embedded in the Loop Band. An accelerometer incorporated in the Loop Band determines when the patient is at rest by constantly monitoring the activity level of the patient. The data is recorded during those resting periods. Using filtering technology for removal of noise (including ambient light) and data processing algorithms, the Loop System stores the raw data collected until it is able to send to the Spry Server.”
Algorithmfiltering technology for removal of noise (including ambient light) and data processing algorithms
source quote (p.5)
“Using filtering technology for removal of noise (including ambient light) and data processing algorithms, the Loop System stores the raw data collected until it is able to send to the Spry Server.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

endpoints: accuracy of heart rate monitoring

standards: ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment, FDA Guidelines for Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff (2013)

Standalone

n=12 patients

endpoints: accuracy of respiration rate monitoring

standards: ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment, FDA Guidelines for Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Drug Administration Staff (2013)

Standalone

n=12 patients

endpoints: accuracy of pulse oximetry monitoring

standards: ISO 80601-2-61 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment, FDA Guidelines for Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Drug Administration Staff (2013)

Reported performance (3 observations)

accuracyas written: “Respiration Rate Accuracy”stated without valueCI 3 RPM ARMS
source quote (p.7)
“3 RPM ARMS”
accuracyas written: “SpO2 Accuracy”stated without valueCI 3% ARMS
source quote (p.8)
“3% ARMS, no motion”
accuracyas written: “Heart Rate Accuracy”stated without valueCI 3 BPM ARMS
source quote (p.8)
“3 BPM ARMS, no motion”

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

10
recalls in product code, 24mo
662
MAUDE reports in code, 12mo
+49%
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/K181352