# K032403: Smartmonitor 2 Professional Series (PS)

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Oct 27, 2003 after 84 days
- Product code: NPF (Monitor, Apnea, Home Use)
- Device class: 2
- Regulation: 21 CFR 868.2377
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962603 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011597: Smartmonitor 2, Model 4000, Respironics Georgia, Inc. (2002)
- K990966: Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-Pediatric/Small Dis, Masimo Corp. (1999) Summary page 1.

## Most influential descendants
- K061256: Smartmonitor 2PS (2006), 0 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1091-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

## Indications for use
The SmartMonitor 2 Professional Series Infant Apnea Monitor is intended for use in the continuous monitoring of respiration, heart rate, and SpO2 of infant patients in a hospital or home environment. The monitor detects and alarms for periods of central apnea, high or low heart rate, and high or low saturation.

Source page: https://510kreport.com/device/K032403
Methodology: https://510kreport.com/methodology