510(k) · Cleared

Cleared

247 BP Device

K070750510(k) AbbreviatedCleared May 2, 200744-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

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

Cleared on May 2, 2007 as substantially equivalent to K002530 (Welch Allyn, Inc., 2000) after a 44-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.

Decided: May 2, 2007
Review: 44 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002530 (2000). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002530 Welch Allyn Spot Check DeviceWelch Allyn, Inc. · 2000
This deviceK070750 247 BP DeviceSuntech Medical, Inc. · 2007
Descendant · cites it directly · 1 of its ownK160439 SunTech CT40 Spot-check Vital Signs DeviceSuntech Medical · 2016
Descendant · 2 generations on · 0 of its ownK192092 Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA…Seca GmbH & Co. KG · 2020

Most influential descendants

Showing 2 of 2 · See all

K160439SunTech CT40 Spot-check Vital Signs DeviceSuntech Medical · 2016 · cites it directly1descendant
K192092Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535Seca GmbH & Co. KG · 2020 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002530	Welch Allyn Spot Check Device	Welch Allyn, Inc.	2000	—
0 (this device)	K070750	247 BP Device	Suntech Medical, Inc.	2007	—
+1	K160439	SunTech CT40 Spot-check Vital Signs Device	Suntech Medical	2016	—
+2	K192092	Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535	Seca GmbH & Co. KG	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2020	1	0

FIG. 1 — Lineage of K070750, 2000–2020Source: 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

Get a 510(k) Report

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
*	K002530	Welch Allyn Spot Check Device Summary page 1 …870.1130 (3) Legally-marketed predicate devices Sun Tech Medical has identified Welch Allyn's Spot Vital Signs, K002530, as the predicate device for the 247. The 247 is substantially equivilent to this device. 507 Airport Bo…	Welch Allyn, Inc.	2000	—

Also cleared against K002530: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K160439	SunTech CT40 Spot-check Vital Signs Device	Suntech Medical	2016	1

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, K160439 (Suntech Medical, 2016) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K002530.

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. 2007, 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 SunTech Medical 247 NIBP, Temperature, and Pulse Oximeter device is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, heart rate, temperature, and functional saturation of arterial hemoglobin (Sp02) of adult and pediatric patients in hospitals, medical facilities, clinics, physicians offices, and other subacute environments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070750 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070750: 247 BP Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070750

Report an extraction error

Are you the manufacturer?

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