# K172959: PeraServer and PeraTrend

- Pathway: 510(k) (Traditional)
- Applicant: Perahealth, Inc.
- Decided: May 1, 2018 after 217 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: 7 generations back to K962603 (1997). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124038: Bedside Paediatric Early Warning System (Bedsidepews), Bedside Clinical Systems, Inc. (2013) Summary page 4.

## Most influential descendants
- K183370: PeraMobile and PeraWatch (2019), 0 descendants of its own

## Indications for use
The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to compute 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. PeraServer is indicated for use wherever there is interest in generating Rothman Index (RI) scores and/or associated configurable warnings. PeraTrend is indicated for use by healthcare providers whenever there is need for displaying and/or trending RI scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraServer/PeraTrend is intended for the care of patients throughout the hospital setting (e.g., in the emergency department, on the wards, in intensive care units). The Rothman Index score is validated for use with neonatal, pediatric, and adult patients. It is an adjunct-to and is not intended to replace vital signs monitoring and is not intended for use in the Neonatal Intensive Care Unit.

Source page: https://510kreport.com/device/K172959
Methodology: https://510kreport.com/methodology