# K112652: Suresigns VS2+ -Suresigns Vsi

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Oct 11, 2011 after 29 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K941811 (1994). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111114: Suresigns VS2 Vital Signs Monitor, Philips Medical Systems (2011)
- K110803: Suresigns Vsi Vital Signs Monitor, Philips Medical Systems (2011)

## Recalls of this device
- Sep 20, 2017 · Class III · Z-0268-2018: Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM.
- Jan 14, 2013 · Class II · Z-0824-2013: VS2+ screen may lock up and stop monitoring during patient use
- Aug 15, 2012 · Class II · Z-2303-2012: Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount

## Indications for use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: * NBP * Spa 2 * Temperature Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: * NBP * SpO2 * Temperature

Source page: https://510kreport.com/device/K112652
Methodology: https://510kreport.com/methodology