# K091068: Accutorr V Monitor, Model 0998-00-2000

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp., Patient Monitoring Division
- Decided: May 8, 2009 after 24 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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: 1 generation back to K983575 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K983575: Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XX, Datascope Corp. (1999) Summary page 1.

## Most influential descendants
- K110156: Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer, (2011), 0 descendants of its own
- K091834: Passport V Monitor, Model 0998-00-6100 (2009), 0 descendants of its own

## Recalls of this device
- Dec 31, 2009 · Not classified · Z-1396-2010: SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.

## Indications for use
The intended use of the Accutorr V is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The physiologic parameters measured includes: noninvasive blood pressure (NIBP), pulse oximetry (SpO 2), heart rate and temperature.

Source page: https://510kreport.com/device/K091068
Methodology: https://510kreport.com/methodology