510(k) · Cleared

Cleared

Ambulo 2400

K080274510(k) TraditionalCleared Apr 23, 200882-day reviewClass II21 CFR 870.1130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tiba Medical, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Apr 23, 2008 as substantially equivalent to K992808 (A&D Medical Div., 1999) after an 82-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.

Decided: Apr 23, 2008
Review: 82 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K992808 (1999). 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK992808 A&D Medical TM-2430 and TM-2431 Ambulatory Blood PressureA&D Medical Div. · 1999
This deviceK080274 Ambulo 2400Tiba Medical, Inc. · 2008
Descendant · cites it directly · 4 of its ownK133989 Ambulo 2400 Ambulatory Blood Pressure Monitoring SystemMortara Instrument, Inc. · 2014
Descendant · 2 generations on · 3 of its ownK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled
Descendant · 3 generations on · 1 of its ownK210139 Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06…Edan Instruments, Inc. · 2021
Descendant · 3 generations on · 0 of its ownK251581 Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026
Descendant · 4 generations on · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026

Most influential descendants

Showing 5 of 5 · See all

K133989Ambulo 2400 Ambulatory Blood Pressure Monitoring SystemMortara Instrument, Inc. · 2014 · cites it directly4descendants
K151520Oscar 2Suntech Medical, Inc. · 2016 · 2 generations on3descendants
K210139Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Edan Instruments, Inc. · 2021 · 3 generations on1descendant
K251581Wearable Ambulatory Blood Pressure Monitor (WBP-02A)Shenzhen Hingmed Medical Instrument Co., Ltd. · 2026 · 3 generations on0descendants
K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K992808	A&D Medical TM-2430 and TM-2431 Ambulatory Blood Pressure	A&D Medical Div.	1999	—
0 (this device)	K080274	Ambulo 2400	Tiba Medical, Inc.	2008	—
+1	K133989	Ambulo 2400 Ambulatory Blood Pressure Monitoring System	Mortara Instrument, Inc.	2014	—
+2	K151520	Oscar 2	Suntech Medical, Inc.	2016	2
+3	K210139	Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09	Edan Instruments, Inc.	2021	—
+3	K251581	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	Shenzhen Hingmed Medical Instrument Co., Ltd.	2026	—
+4	K251591	Holter ECG and ABP system (HolterABP)	Edan Instruments, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2016	1	0
2021	1	0
2026	2	0

FIG. 1 — Lineage of K080274, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DXN device

#1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K992808	A&D Medical TM-2430 and TM-2431 Ambulatory Blood Pressure Summary page 1 …The Arrbulo 2400 is substantially equivalent to the A&D Medical model TM-2430 Ambulatory Blood Pressure Monitoring system cleared for marker under K992808. Device Description: The Ambulo 2400 is a compact, lightweight, non-invasive ambulatory blood monitoring sys…	A&D Medical Div.	1999	—

Also cleared against K992808: 2 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133989	Ambulo 2400 Ambulatory Blood Pressure Monitoring System	Mortara Instrument, Inc.	2014	4

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K133989 (Mortara Instrument, Inc., 2014) has gone furthest, with 4 descendants of its own.
2 other devices also cite its predicate K992808.

How does its category compare?

All DXN devices

DXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DXN

28in 2025

2007high 46 (2009) · low 17 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXN

142in 2025

2007high 235 (2018) · low 72 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXN

3in 2024

2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXN

239in 2025

2007high 617 (2018) · low 8 (2008)2025

MAUDE reports naming product code DXN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	27	118	0	21
2008	23	82	1	8
2009	46	73	3	17
2010	43	94	0	14
2011	34	72	1	10
2012	36	116	0	19
2013	34	150	1	72
2014	29	133	0	47
2015	30	97	0	62
2016	30	144	1	54
2017	33	184	0	90
2018	22	235	0	617
2019	33	156	1	96
2020	24	198	0	130
2021	23	190	0	162
2022	25	137	0	155
2023	35	182	0	162
2024	17	107	3	270
2025	28	142	0	239
2026	29	147	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080274 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080274: Ambulo 2400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080274

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026