# K093907: Welch Allyn Non Invasive Blood Pressure (Nibp) Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Apr 14, 2010 after 113 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: 8 generations back to K962603 (1997). 18 ancestors in all.
74 later devices descend from it; 1 cites it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063419: Modification to VSM- Vital Signs Monitor, (VSM 300 ), Welch Allyn Protocol, Inc. (2006) Summary page 1.
- K040490: Welch Allyn Spot Ultra Vital Signs Device, Welch Allyn, Inc. (2004) Summary page 1.

## Most influential descendants
- K101445: Vital Signs Monitor-VSM 6000 Series (2010), 73 descendants of its own
- K110516: Connex Vital Signs Monitor 6000 Series (2011), 67 descendants of its own
- K112687: Connex (R) Vital Signs Monitor 6000 Series (2011), 66 descendants of its own
- K121013: Connex Vital Signs Monitor 6000 Series (2012), 65 descendants of its own
- K140188: Masimo Root Monitoring System (2014), 58 descendants of its own

## Indications for use
The Welch Allyn Non-Invasive Blood Pressure device is intended to be used by clinicians and medically qualified personnel for the acquisition and attended monitoring of noninvasive blood pressure and pulse rate of neonatal through adult patients. The Welch Allyn Non-Invasive Blood Pressure device may be used for treatment and diagnostic spot NIBP measurements or attended NIBP monitoring in hospital general wards, clinics, and doctor's offices.

Source page: https://510kreport.com/device/K093907
Methodology: https://510kreport.com/methodology