Cardiovascular · 510(k) · 2026
Perin Health System (PHD80060-2)
Perin Health Devices, LLC. Cleared by FDA on 22 January 2026 under submission K252984, product code DRG (transmitters and receivers, physiological signal, radiofrequency). What FDA's record says, in FDA's words.
Device record · K252984
- Device. Perin Health System (PHD80060-2)DEVICE
- Company. Perin Health Devices, LLCCOMPANY
- Decision. 22 January 2026, 510(k), substantially equivalent (traditional review); received 18 September 2025DECISION
- Panel. CardiovascularPANEL
- Product code. DRG, Transmitters And Receivers, Physiological Signal, RadiofrequencyCODE
- Regulation. 21 CFR 870.2910, Class IIREG
- Source. FDA database entry · decision document (26 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.
The Perin Health Platform is a wireless remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in healthcare and home settings for long-term monitoring. The Perin Health Patch can monitor auscultation data of heart and lung sounds, photoplethysmography waveforms (PPG), oxygen sat uration (%SpO2), heart rate, electrocardiography (ECG), heart rate variability, R-R interv al, resp iratory rate, skin tempera ture, activity detection (including step count), and posture (body position relative to gravity including fall). The Perin Health System is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. In home-use environments, the Perin Health Platform is able to integrate with optional third-party devices for blood pressure, and weight data collection via the mobile application. The mobile application transmits data from the Health Patch and third party devices to the cloud and web-based portal for storage, analysis, and review by healt hcare professionals. The Perin Health Platform can include the ability to notify healthcare professionals when physiological data falls outside set limits or manual trigger by the patient. The device is intended to provide physiological information for non-critical, adult population.
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.
- Modalities namedECG
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsadult patients
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 2026. 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.