510(k) · Cleared

Cleared

Calhealth, Inc., Finger Blood Pressure Monitor, Mdmouse

K081924510(k) TraditionalCleared Jan 7, 2009184-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

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

Cleared on Jan 7, 2009 as substantially equivalent to K894563 (Omron Electronics, Inc., 1990) after a 184-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Jan 7, 2009
Review: 184 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K894563 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK894563 Omron Digital Blood Pressure Monitor Model HEM814FOmron Electronics, Inc. · 1990
This deviceK081924 Calhealth, Inc., Finger Blood Pressure Monitor, MdmouseCalhealth, Inc. · 2009
Descendant · cites it directly · 0 of its ownK261061 BP Go (BPP-855)Wellvii, Inc. · 2026

Most influential descendants

Showing 1 of 1 · See all

K261061BP Go (BPP-855)Wellvii, Inc. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894563	Omron Digital Blood Pressure Monitor Model HEM814F	Omron Electronics, Inc.	1990	—
0 (this device)	K081924	Calhealth, Inc., Finger Blood Pressure Monitor, Mdmouse	Calhealth, Inc.	2009	—
+1	K261061	BP Go (BPP-855)	Wellvii, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K081924, 1990–2026Source: 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

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
*	K894563	Omron Digital Blood Pressure Monitor Model HEM814F Summary page 1 …stem NAME: (21CFR 870.1130) PRODUCT CODE: DX CLASSIFICATION CARDIOVASCULAR PANEL: PREDICATED Omron Digital Finger Blood Pressure Monitor (K894563) DEVICE: INTENDED USE: The Cafl~ealth Finger Blood Pressure Monitor, MDMouse is noninvasive blood pressu…	Omron Electronics, Inc.	1990	—
†	K051539	Tricot Blood Pressure Cuff	Ya Horng Electronic Co., Ltd.	2005	—

Also cleared against K894563: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K261061	BP Go (BPP-855)	Wellvii, Inc.	2026	0

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, K261061 (Wellvii, Inc., 2026) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K894563.

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. 2009, 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 CalHealth Finger Blood Pressure Monitor, MDMouse is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the left index finger.

The cuff circumference is designed for Left Index Finger circumference: 1.5' - 3.5' (3.7 -8.8 cm) for finger type.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081924 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081924: Calhealth, Inc., Finger Blood Pressure Monitor, Mdmouse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081924

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