# K152831: Spot Skan

- Pathway: 510(k) (Traditional)
- Applicant: Skanray Technologies Private Limited
- Decided: Feb 23, 2016 after 147 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
Longest line of descent: 9 generations back to K941811 (1994). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101680: Welch Allyn Spot Vital Signs Lxi Model 45000 Series, Welch Allyn, Inc. (2010) Summary page 5.
- K120132: Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs Monitor, Philips Medical Systems (2012) Summary page 5.
- K060820: Cycle BP Monitor and Pulse Oximeter, Model 1060, Suntech Medical, Inc. (2006) Summary page 5.
- K103763: Stellar 300, Larsen & Toubro Limited (2011) Summary page 5.

## Indications for use
SpotSkan, a multi-parameter Spot Check Device, along with the appropriate accessories mentioned / supplied with the unit, is intended to measure a single adult or pediatric (but not neonatal) patient’s vital signs at the physician’s clinic. SpotSkan is not a Patient Monitor. Vital signs measured include SpO2, Non-Invasive Blood Pressure, Pulse Rate and Temperature. A thermal recorder is provided for printing measured data. The user is responsible to interpret the measured data made available, and shall be a professional health care provider. The monitor is not intended for home use.

Source page: https://510kreport.com/device/K152831
Methodology: https://510kreport.com/methodology