# K023616: Physiological Monitor, Model 3000 (Series)

- Pathway: 510(k) (Special)
- Applicant: Ivy Biomedical Systems, Inc.
- Decided: Nov 4, 2002 after 6 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K092809: HRV Acquire (2010), 0 descendants of its own

## Indications for use
The Ivy Biomedical Model 3000 Patient Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 3000 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.

Source page: https://510kreport.com/device/K023616
Methodology: https://510kreport.com/methodology