Cardiovascular · 510(k) · 2023
Alio
Alio, Inc.. Cleared by FDA on 17 March 2023 under submission K223073, product code DRG (transmitters and receivers, physiological signal, radiofrequency). What FDA's record says, in FDA's words.
Device record · K223073
- Device. AlioDEVICE
- Company. Alio, Inc.COMPANY
- Decision. 17 March 2023, 510(k), substantially equivalent (traditional review); received 30 September 2022DECISION
- Panel. CardiovascularPANEL
- Product code. DRG, Transmitters And Receivers, Physiological Signal, RadiofrequencyCODE
- Regulation. 21 CFR 870.2910, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
to include measurements of hemoglobin (Hgb) and hematocrit (Hct) and a qualitative indicator of abnormal potassium levels. Additionally, the device is being indicated for both clinical and non-clinical settings. • Addition of an artificial intelligence/machine learning (AI/ML) algorithm used in the calculation of the new physiologic parameters • Modification of the adhesive used to secure the device to the patient • Minor cosmetic dimensional changes to the Alio SmartPatch A lio and Alio Medical Remote Monitoring System (K211365) have the same intended use and similar indications, technolo gical characteristics and principles of operation. The differences described above do not present any new issues of safety or effectiveness and have undergone non-
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1,732 reports filed against devices carrying product code DRG. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
17 September 2026 · Malfunction · ORG-9110A · Nihon Kohden Corporation · report 8030229-2026-07149
16 September 2026 · Malfunction · ORG-9110A · Nihon Kohden Corporation · report 8030229-2026-07147
The Biomedical Engineer (Biomed) reported that at the Central Nurse's Station (CNS), the ZM tele was swapping between 3 different patient's names. Those were the last 3 patients admitted on this tele before the current patient was admitted. No patient harm was reported.
9 September 2026 · Malfunction · Surveyor S4 · BAXTER HEALTHCARE CORPORATION · report 3006087789-2026-00021
4 September 2026 · Malfunction · ORG-9110A · Nihon Kohden Corporation · report 8030229-2026-07105
2 September 2026 · Malfunction · ORG-9110A · Nihon Kohden Corporation · report 8030229-2026-07098
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DRG, in Cardiovascular, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.