# K091985: Universal Physiological Measurement Module

- Pathway: 510(k) (Special)
- Applicant: Ivy Biomedical Systems, Inc.
- Decided: Jul 24, 2009 after 22 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Universal Physiological Measurement Module is intended for use on patients requiring R-wave synchronization and timed imaging studies. Applications include: gamma cameras, TMR/PMR, multislice CT, PET/CT, and SPECT/CT. The UPMM is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.

Source page: https://510kreport.com/device/K091985
Methodology: https://510kreport.com/methodology