# K102988: Electronic Blood Presure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Pango Electronic Co., Ltd.
- Decided: Nov 9, 2010 after 34 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: 3 generations back to K001670 (2000). 3 ancestors in all.
23 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070828: KD-595 Fully Automatic Electronic Blood Pressure Monitor, Kodon (Tianjin)Electronic&Electrical Apparatus Co., (2007) Summary page 1.

## Most influential descendants
- K131558: PG-800B Series, Including PG-800BD, PG-800B-1, PG-800BD-1, PG-800B3, PG-800B4, PG-800B4D, PG-800B5, PG-800B5-1, PG-800B6 (2013), 22 descendants of its own
- K170151: Electronic Blood Pressure Monitor (2017), 19 descendants of its own
- K182495: Electronic Blood Pressure Monitor (2019), 11 descendants of its own
- K191180: Electronic Blood Pressure Monitor (2019), 10 descendants of its own
- K222125: Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G (2022), 4 descendants of its own

## Indications for use
PG-800B Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended arm circumference is 22-32 cm.

Source page: https://510kreport.com/device/K102988
Methodology: https://510kreport.com/methodology