# K080274: Ambulo 2400

- Pathway: 510(k) (Traditional)
- Applicant: Tiba Medical, Inc.
- Decided: Apr 23, 2008 after 82 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 K992808 (1999). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992808: A&D Medical TM-2430 and TM-2431 Ambulatory Blood Pressure, A&D Medical Div. (1999) Summary page 1.

## Most influential descendants
- K133989: Ambulo 2400 Ambulatory Blood Pressure Monitoring System (2014), 4 descendants of its own
- K151520: Oscar 2 (2016), 3 descendants of its own
- K210139: Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 (2021), 1 descendant of its own
- K251581: Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (2026), 0 descendants of its own
- K251591: Holter ECG and ABP system (HolterABP) (2026), 0 descendants of its own

## Indications for use
The Ambulo 2400 Ambulatory Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure and pulse rate of adults who are eighteen (18) years and older, using the oscillometric method on a cuffed arm.

Source page: https://510kreport.com/device/K080274
Methodology: https://510kreport.com/methodology