# K061256: Smartmonitor 2PS

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Aug 2, 2006 after 90 days
- Product code: NPF (Monitor, Apnea, Home Use)
- Device class: 2
- Regulation: 21 CFR 868.2377
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K910772 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032403: Smartmonitor 2 Professional Series (PS), Respironics, Inc. (2003) Summary page 1.
- K982776: 9303 Neonatal/Adult Vital Signs Monitor, Cas Medical Systems, Inc. (1998) Summary page 1.

## Recalls of this device
- May 1, 2017 · Class II · Z-2250-2017: Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "
- Apr 29, 2014 · Class II · Z-1789-2014: The battery pack wire harness is improperly assembled rendering the device inoperable. The wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at p
- Oct 15, 2007 · Not classified · Z-1086-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

## Indications for use
The SmartMonitor 2PS is intended for use in the continuous monitoring of respiration, heart rate and SpO₂ levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment. The SmartMonitor 2PSL is intended for use in the continuous monitoring of respiration, and heart rate of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, and high or low breath rate. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.

Source page: https://510kreport.com/device/K061256
Methodology: https://510kreport.com/methodology