510(k) · Cleared

Cleared

Welch Allyn Abpm 6100

K021756510(k) SpecialCleared Jun 27, 200229-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

Welch Allyn, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Jun 27, 2002 as substantially equivalent to K010622 (Suntech Medical Instruments, Inc., 2001) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1993. 6 later devices descend from it.

Decided: Jun 27, 2002
Review: 29 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K925899 (1993). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK925899 Ambulatory Blood Pressure Monitor, MDL# 5100-01Welch Allyn, Inc. · 1993
This deviceK021756 Welch Allyn Abpm 6100Welch Allyn, Inc. · 2002
Descendant · cites it directly · 5 of its ownK082881 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2008
Descendant · 2 generations on · 3 of its ownK093013 Blood Pressure Monitor, Model MD200ABeijing Choice Electronic Technololgy Co., Ltd. · 2010
Descendant · 2 generations on · 0 of its ownK202729 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2021
Descendant · 3 generations on · 0 of its ownK130056 Patient MonitorLd Technology, LLC · 2013
Descendant · 3 generations on · 0 of its ownK110775 Electronic SphygmomanometerContec Medical Systems Co.,Ltd · 2011

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008high 2 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all

K082881Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3Microlife Intellectual Property GmbH · 2008 · cites it directly5descendants
K093013Blood Pressure Monitor, Model MD200ABeijing Choice Electronic Technololgy Co., Ltd. · 2010 · 2 generations on3descendants
K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2021 · 2 generations on0descendants
K130056Patient MonitorLd Technology, LLC · 2013 · 3 generations on0descendants
K110775Electronic SphygmomanometerContec Medical Systems Co.,Ltd · 2011 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925899	Ambulatory Blood Pressure Monitor, MDL# 5100-01	Welch Allyn, Inc.	1993	—
0 (this device)	K021756	Welch Allyn Abpm 6100	Welch Allyn, Inc.	2002	—
+1	K082881	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3	Microlife Intellectual Property GmbH	2008	—
+2	K093013	Blood Pressure Monitor, Model MD200A	Beijing Choice Electronic Technololgy Co., Ltd.	2010	—
+2	K202729	Microlife Upper Arm Automatic Digital Blood Pressure Monitor	Microlife Intellectual Property GmbH	2021	—
+3	K130056	Patient Monitor	Ld Technology, LLC	2013	—
+3	K110775	Electronic Sphygmomanometer	Contec Medical Systems Co.,Ltd	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0
2011	2	0
2013	1	0
2021	1	0

FIG. 1 — Lineage of K021756, 1993–2021Source: 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? (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
*	K010622	Pressure Trak, Model 222-B	Suntech Medical Instruments, Inc.	2001	—
*	K925899	Ambulatory Blood Pressure Monitor, MDL# 5100-01 Summary page 1 …Welch Allyn Ambulatory Blood Pressure Monitor Welch Allyn, Inc. 5 1O(k) Document Control Number K925899 Page 10 Y Welch Allyn ABPM 6100 Pve-market Notification D…	Welch Allyn, Inc.	1993	—

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K082881	Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp O3	Microlife Intellectual Property GmbH	2008	5

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.
Of its descendants, K082881 (Microlife Intellectual Property GmbH, 2008) has gone furthest, with 5 descendants of its own.

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 Welch Allyn ABPM 6100 is a non-invasive oscillometric ambulatory blood pressure monitor that is to be used with ABPM 6100 Software, a PC based computer program. The ABPM 6100 is capable of recording and displaying up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure adult or pediatric patients systolic'and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021756 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021756: Welch Allyn Abpm 6100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021756

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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