# K952054: Siemens Sirecust Monitoring (1200, 1200 Neo, 960)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 7, 1996 after 403 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K844187 (1985). 1 ancestor in all.
252 later devices descend from it; 2 cite it directly.
0 of 254 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844187: Siemens Sirecust 404N Neonatal Monitor, Siemens Medical Solutions USA, Inc. (1985) Summary page 5.

## Most influential descendants
- K962404: Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System (1997), 247 descendants of its own
- K993974: Siemens Infinity SC 6002XL Portable Patient Monitor (2000), 246 descendants of its own
- K033600: Infinity Gammaxl (2003), 244 descendants of its own
- K040188: Infinity Gammaxl and SC 6802XL with the Scio Gas Module (2004), 241 descendants of its own
- K051628: Infinity Monitors with Scio Modifications (2005), 230 descendants of its own

## Indications for use
The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlicr versions of these products. The Intended Use Statement for the enhanced software is the same as the Intended Use for the substantially equivalent software of the Model 404N (reference S10(K) 844187/A). The intended use of this software is to measure: heart rate, respiration rate, invasive blood pressure, noninvasive blood pressure, cardiac output, gascous carbon dioxide level, temperature, artial oxygen concentration and pulse rate in neonatal patients and to detect ventilator performance and electroencephalograph waveforms. The software will produce visual and aural alarms if any of these parameters vary beyond preset limits.

Source page: https://510kreport.com/device/K952054
Methodology: https://510kreport.com/methodology