# K983575: Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XX

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: May 13, 1999 after 212 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
122 later devices descend from it; 3 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX (2000), 119 descendants of its own
- K032733: PM-8000 Patient Monitor, Model 8000 (2004), 88 descendants of its own
- K043348: Modification to PM-8000 Patient Monitor (2005), 87 descendants of its own
- K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX (2002), 75 descendants of its own
- K053234: PM-9000 Express Patient Monitor (2006), 71 descendants of its own

## Indications for use
The indications for use for the Accutorr Plus include the monitoring of the following human physiological vital signs: Blood Oxygenation (SpO₂) measurement Temperature measurement Non Invasive Blood Pressure (NIBP) measurement Heart Rate derived from selected source (SpO₂, NIBP) The target populations are adult, pediatric and neonate populations. The monitor is intended for use within the health care facility setting.

Source page: https://510kreport.com/device/K983575
Methodology: https://510kreport.com/methodology