# K183370: PeraMobile and PeraWatch

- Pathway: 510(k) (Traditional)
- Applicant: Perahealth, Inc.
- Decided: Sep 11, 2019 after 281 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172959: PeraServer and PeraTrend, Perahealth, Inc. (2018) Summary page 4.

## Indications for use
PeraMobile Indications for Use: The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient’s physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient’s vital signs, nursing assessments, and selected lab values. PeraMobile is indicated for use by healthcare providers within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraMobile is intended for use in the hospital to support Rapid Response Team clinicians or other dedicated clinical response staff responsible for pro-actively rounding on patients of concern and/or providing supplemental support to bedside clinicians. PeraWatch Indications for Use: The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient’s physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient’s vital signs, nursing assessments, and selected lab values. PeraWatch is indicated for use by healthcare providers whenever there is need within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraWatch is intended to support clinicians in surveilling patients throughout the hospital setting (e.g. in the emergency department, on the wards, in intensive care units) and across multiple hospitals in a centralized and/or remote professional clinical surveillance setting.

Source page: https://510kreport.com/device/K183370
Methodology: https://510kreport.com/methodology