510(k) · Cleared

Cleared

BR 102 Plus Blood Pressure Holter System

K051368510(k) TraditionalCleared Aug 9, 200576-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

Schiller AG · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Aug 9, 2005 as substantially equivalent to K913844 (Suntech Medical Instruments, Inc., 1992) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1992.

Decided: Aug 9, 2005
Review: 76 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K913844 (1992). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK913844 Accutracker DXSuntech Medical Instruments, Inc. · 1992
This deviceK051368 BR 102 Plus Blood Pressure Holter SystemSchiller AG · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913844	Accutracker DX	Suntech Medical Instruments, Inc.	1992	—
0 (this device)	K051368	BR 102 Plus Blood Pressure Holter System	Schiller AG	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K051368, 1992–2005Source: 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
*	K913844	Accutracker DX Summary page 2 …ame: Non-Invasive Blood Pressure Measurement System, 21 CFR §870.1130, DXN, Class 11 Legally-marketed predicate devices Accutracker DX, K91 3844, SunTech Medical Instruments Inc. Oscar 2 Model 222, K003004, SunTech Medical Instruments Inc. The BR-i 02 plus is substantia…	Suntech Medical Instruments, Inc.	1992	—
*	K003004	Oscar 2, Model 222 Summary page 2 …21 CFR §870.1130, DXN, Class 11 Legally-marketed predicate devices Accutracker DX, K91 3844, SunTech Medical Instruments Inc. Oscar 2 Model 222, K003004, SunTech Medical Instruments Inc. The BR-i 02 plus is substantially equivalent to the above mentioned devices. Description…	Suntech Medical Instruments, Inc.	2000	—

Also cleared against K913844: 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?

None of the 2 ancestors has a recall.
2 other devices also cite its predicate K913844.

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.

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 BR-102 plus is a non-invasive ambulatory blood pressure monitor. It uses auscultatoric and oscillometric signals to measure the blood pressure of human beings, or uses purely the oscillometric signals. Systolic, diastolic, mean arterial pressure and the heart rate are measured. The BR-102 plus is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult or adolescent patient's blood pressure over an extended period of time (up to 48h). The BR-102 plus can be used for patients of both sexes and all races. The BR-102 plus should not be used with neonates.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051368 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051368: BR 102 Plus Blood Pressure Holter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051368

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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