# K970061: Accutorr Plus Non Invasive Blood Pressure Monitor (0998-00-0117-XX)

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Sep 25, 1997 after 261 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## 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 the adult and pediatric populations. The monitor is intended for use within the health care facility setting.

Source page: https://510kreport.com/device/K970061
Methodology: https://510kreport.com/methodology