Rooti Rx ECG Event Recorder, Rooti Link APP Software

K163694

Rooti Labs Ltd. · cleared 2017-11-07 · product code DRG · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.5)
“Rooti Rx System is a wearable single lead ECG recording device, composed by Rooti Rx, patch, charging dock and Rooti Link.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (0)

FDA source did not describe a validation study.

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

1
recalls in product code, 24mo
77
MAUDE reports in code, 12mo
+240%
vs code's own 3-yr baseline
2
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code DRG: 77 in the 12 months ending 2026-06, vs a 22.7/12mo average over the prior 3 windows (+240%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=DRG

  • recall_reason_pattern

    Software/algorithm-related recall in product code DRG (Biointellisense Inc. 570 El Camino Real, initiated 2024-07-19): "Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:94943

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/K163694