physIQ Heart Rhythm and Respiratory Module

K183322

physIQ, Inc · cleared 2019-07-10 · product code DPS · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The physIQ Heart Rhythm and Respiration Module (Version 2.0) is a computerized all-software callable function library in the Python programming language that is designed for calculating heart rate and heart rate variability and for detecting atrial fibrillation and determining respiration rate determined by automated analysis of any single electrocardiogram (ECG) channel collected by commercially-available ECG biosensor devices with triaxial accelerometers. Both the physIQ Heart Rhythm and Respiration Module and the physIQ Heart Rhythm Module predicate have similar safety and technological characteristics as both are all software medical devices and require input of time-series ECG from commercially available devices in a format acceptable for signal processing and algorithm function.”
Algorithmcollection of algorithms intended to be applied to ECG data collected by commercially-available ECG biosensor devices with triaxial accelerometers in an ambulatory setting. The collection consists of Heartbeat Detector, Heart Rate, Heart Rate Variability, Atrial Fibrillation and Respiration Rate algorithms.
source quote (p.5)
“The physIQ Heart Rhythm and Respiration Module (Version 2.0) contains a collection of algorithms intended to be applied to ECG data collected by commercially-available ECG biosensor devices with triaxial accelerometers in an ambulatory setting. The collection consists of Heartbeat Detector, Heart Rate, Heart Rate Variability, Atrial Fibrillation and Respiration Rate algorithms.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

sample size not stated

endpoints: respiration rate algorithm met its corresponding acceptance criteria; performed comparably to the predicate device

Bench

sample size not stated

endpoints: respiration rate algorithm met its corresponding acceptance criteria; performed comparably to the predicate device

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

9
recalls in product code, 24mo
72
MAUDE reports in code, 12mo
+26%
vs code's own 3-yr baseline
3
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Braemar Manufacturing, LLC, initiated 2024-12-18): "Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring se" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95837

  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Baxter Healthcare Corporation, initiated 2024-10-11): "There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95559

  • recall_reason_pattern

    Software/algorithm-related recall in product code DPS (Schiller, Ag Altgasse 68 Baar Switzerland, initiated 2024-07-24): "Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95074

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/K183322