FDA 510(k) · Medtronic
K153160: AVIVO Mobile Patient Management (MPM) System (Medtronic, Inc.)
Medtronic, Inc. received FDA 510(k) K153160 for AVIVO Mobile Patient Management (MPM) System, with a decision date of Mar 30, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K153160 |
|---|---|
| Pathway | 510(k) |
| Applicant | Medtronic, Inc. |
| Device name | AVIVO Mobile Patient Management (MPM) System |
| Product code | MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Regulation (21 CFR) | 870.1025 |
| Device class | Class 2 |
| Date received | Nov 2, 2015 |
| Decision date | Mar 30, 2016 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The AVIVO™ Mobile Patient Management (MPM) System is intended to continuously measure, record and periodically transmit physiological data. The AVIVO™ MPM System is indicated for patients: • With fluid management problems • Taking diuretic medication • Living with heart failure • Living with end-stage renal disease • Suffering from recurrent dehydration • Who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The AVIVO™ MPM System monitors, derives and displays: • ECG • Heart Rate (including HR variability) • Activity • Posture • Respiration Rate (including RR variability) • Body Fluid Status The system has not been tested specifically for pediatric use.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MHX is "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)", class 2, 21 CFR 870.1025.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor Unknown. These are heuristics, not FDA fields.