MATRx plus

K163665

Zephyr Sleep Technologies · cleared 2017-05-05 · product code MNR · Anesthesiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The MATRx plus is a new ventilatory effort recorder device. The MATRx plus recorder is a 5-channel battery-powered respiratory pressure sensor and oximetry system. MATRX plus provides recordings of respiratory pressure, respiratory effort, pulse rate, oxygen saturation, snoring and body position during sleep. The physician prescribed device is worn on the patient's abdomen attached to a reusable effort belt and all relevant respiratory information during sleep is collected via nasal cannula, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the MATRx plus recorder and fixed at the patient's nose. The cannula is dual lumen and functions to individually sample the pressure from each naris. The oximetry sensor is fixed at the patient's finger and connects directly to the device. The Recorder receives input from the sensors and wirelessly transmits the data to a bedside Tablet during the study.Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients.”
AlgorithmAutoscoring algorithm for ODI
source quote (p.12)
“Autoscoring algorithm for ODI was compared with the Snore SAT monitor output (K002159) on data from 179 patients.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.10)
“Removal of USB port to increase cybersecurity features of the device.”

Validation studies (1)

Retrospective clinical

n=179 patients

standards: IEC 60601-1-11:2010, IEC 60601-1:2005+1, IEC 60601-1-2:2007, IEC 60601-1:2005, IEC 62304:2006, IEC 62133:2012

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

0
recalls in product code, 24mo
37
MAUDE reports in code, 12mo
+171%
vs code's own 3-yr baseline
1
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code MNR: 37 in the 12 months ending 2026-06, vs a 13.7/12mo average over the prior 3 windows (+171%). 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=MNR

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 Anesthesiology 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/K163665