510(k) · Cleared

Cleared

Vantage Abi

K103693510(k) TraditionalCleared Feb 15, 201160-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

Summit Doppler Systems, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Feb 15, 2011 as substantially equivalent to K042616 (Biomedix, Inc., 2004) and 1 other predicate after a 60-day review. Its family tree reaches back 2 generations to 1997.

Decided: Feb 15, 2011
Review: 60 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K973644 (1997). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK973644 Flostat Vascular LabBiomedix, Inc. · 1997
1 generation backK042616 Biomedix Padnet LabBiomedix, Inc. · 2004
This deviceK103693 Vantage AbiSummit Doppler Systems, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K973644	Flostat Vascular Lab	Biomedix, Inc.	1997	—
−1	K042616	Biomedix Padnet Lab	Biomedix, Inc.	2004	—
0 (this device)	K103693	Vantage Abi	Summit Doppler Systems, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2006	1	0

FIG. 1 — Lineage of K103693, 1997–2011Source: 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? (2)

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
*	K042616	Biomedix Padnet Lab Summary page 1 …alence: The Vantage ABI is substantially equivalent to the cleared devices shown below. Blo~edix, PADnet K(042616, Cleared 10/12/2004 Summit Doppler Systems, Vista AVS K063600, Cleared…	Biomedix, Inc.	2004	—
*	K063600	Vista Avs Summary page 1 …Blo~edix, PADnet K(042616, Cleared 10/12/2004 Summit Doppler Systems, Vista AVS K063600, Cleared 12/22/2006 Technologies Summary: This device uses pneumatic volume plethysmography recording (PVR) and…	Summit Doppler Systems, Inc.	2006	—

Also cleared against K042616: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K042616.

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. 2011, 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 Vantage ABI is a non-invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103693 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103693: Vantage Abi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103693

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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