# K011597: Smartmonitor 2, Model 4000

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics Georgia, Inc.
- Decided: Jan 11, 2002 after 232 days
- Product code: FLS (Monitor, Apnea, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.2377
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K892006 (1989). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892006: Healthdyne's Apnea/Heart Monitor, Model 900S, Healthdyne, Inc. (1989) Summary page 1.

## Most influential descendants
- K032403: Smartmonitor 2 Professional Series (PS) (2003), 1 descendant of its own
- K061256: Smartmonitor 2PS (2006), 0 descendants of its own

## Recalls of this device
- Apr 23, 2009 · Not classified · Z-1411-2009: Audible alarm failure.
- Oct 15, 2007 · Not classified · Z-1093-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.

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

Source page: https://510kreport.com/device/K011597
Methodology: https://510kreport.com/methodology