# K021756: Welch Allyn Abpm 6100

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Jun 27, 2002 after 29 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: 1 generation back to K925899 (1993). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010622: Pressure Trak, Model 222-B, Suntech Medical Instruments, Inc. (2001)
- K925899: Ambulatory Blood Pressure Monitor, MDL# 5100-01, Welch Allyn, Inc. (1993) Summary page 1.

## Most influential descendants
- K082881: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3 (2008), 5 descendants of its own
- K093013: Blood Pressure Monitor, Model MD200A (2010), 3 descendants of its own
- K202729: Microlife Upper Arm Automatic Digital Blood Pressure Monitor (2021), 0 descendants of its own
- K130056: Patient Monitor (2013), 0 descendants of its own
- K110775: Electronic Sphygmomanometer (2011), 0 descendants of its own

## Indications for use
The Welch Allyn ABPM 6100 is a non-invasive oscillometric ambulatory blood pressure monitor that is to be used with ABPM 6100 Software, a PC based computer program. The ABPM 6100 is capable of recording and displaying up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure adult or pediatric patients systolic'and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnosis.

Source page: https://510kreport.com/device/K021756
Methodology: https://510kreport.com/methodology