# K964408: Poseidon Cardiac Monitoring System (PCMS)

- Pathway: 510(k) (Traditional)
- Applicant: Instromedix, Inc.
- Decided: Jul 23, 1997 after 261 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864318 (1987). 7 ancestors in all.
123 later devices descend from it; 4 cite it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864318: The Buddy System/Health Information System, The Buddy Systems, Inc. (1987) Summary page 1.
- K871748: The Buddy System W/Optional Ecg Electrode, The Buddy Systems, Inc. (1987) Summary page 1.
- K952979: Hanc Network, Healthtech Services Corp. (1996) Summary page 1.

## Most influential descendants
- K993169: Modification of: Physiological Signal Transmitter and Receiver, Model 3810A (1999), 103 descendants of its own
- K023749: The M3810A Philips Telemonitoring System with M3812B Telestation (M310A/12B) (2002), 98 descendants of its own
- K031840: Carematix Wellness System (2003), 90 descendants of its own
- K040966: Modification to Carematix Wellness System (2004), 86 descendants of its own
- K041816: RTX3320PSTN Wireless Telehealth Gateway (2004), 59 descendants of its own

## Indications for use
Monitoring of stable patients, not at high risk for life-threatening arrhythmias, after discharge from hospital stay, such as patients with compensated congestive heart failure, patients whose myocardial infarction is not recent, or patients with a stabilized heart condition following open heart surgery or coronary artery disease Monitoring of patients in out-of-hospital convalescence settings Monitoning of patients by physicians, clinics, or skilled care facilities Any time a health care professional desires monitoring, measuring or recording of a patient's ECG, SpO₂, and/or blood pressure in an out of hospital residence setting The device is not intended to sound real time alarms This device does not replace physician's care

Source page: https://510kreport.com/device/K964408
Methodology: https://510kreport.com/methodology