510(k) · Cleared

Cleared

Hommed Sentry Iiib-F Patient Monitor System

K040651510(k) TraditionalCleared Aug 10, 2004152-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

Hommed, LLC · DXN System, Measurement, Blood-Pressure, Non-Invasive

Cleared on Aug 10, 2004 as substantially equivalent to K014025 (Hommed, LLC, 2002) after a 152-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.

Decided: Aug 10, 2004
Review: 152 days
Class: Class II
Product code: DXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K014025 (2002). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK014025 Hommed Sentry Iii Patient Monitor System with Card ReaderHommed, LLC · 2002
This deviceK040651 Hommed Sentry Iiib-F Patient Monitor SystemHommed, LLC · 2004
Descendant · cites it directly · 0 of its ownK061088 Sentry Otc MonitorHoneywell Hommed, LLC · 2006
Descendant · cites it directly · 0 of its ownK050951 Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360…Cibernet Systems Corp. · 2005 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K061088Sentry Otc MonitorHoneywell Hommed, LLC · 2006 · cites it directly0descendants
K050951Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model 533-360…Cibernet Systems Corp. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K014025	Hommed Sentry Iii Patient Monitor System with Card Reader	Hommed, LLC	2002	—
0 (this device)	K040651	Hommed Sentry Iiib-F Patient Monitor System	Hommed, LLC	2004	—
+1	K061088	Sentry Otc Monitor	Honeywell Hommed, LLC	2006	—
+1	K050951	Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model…	Cibernet Systems Corp.	2005	4

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0

FIG. 1 — Lineage of K040651, 2002–2006Source: 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? (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
*	K014025	Hommed Sentry Iii Patient Monitor System with Card Reader Summary page 1 …me: Cardiovascular and Respiratory Devices, Class II Substantial Equivalence Claimed to: HomMed Sentry III Patient Monitor System with Card Reader K014025 Device Description: The HomMed Sentry IIIB-F Patient Monitor System (Sentry IlIB-F) is a portable…	Hommed, LLC	2002	—

Also cleared against K014025: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061088	Sentry Otc Monitor	Honeywell Hommed, LLC	2006	0
K050951	Medstar 220, Model 533-220; Medstar 230, Model 533-230; Medstar 360, Model 533-360…	Cibernet Systems Corp.	2005	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, K061088 (Honeywell Hommed, LLC, 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K014025.

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 HomMed Sentry 111B-F Patient Monitor System is designed to measure Patient Vital Signs in the home by patients or in clinical environments by health care providers. The HomMed Sentry 111B-F Patient Monitor System is available with physicians' orders only. The HomMed Sentry IllB-F Patient Monitor System measures the following parameters: Non-Invasive Blood Pressures (Systolic, Diastolic and Mean Arterial Pressure), Functional Oxygen Saturation (%SP 0…

Read the full statement (145 words)

The HomMed Sentry IllB-F Patient Monitor System measures the following parameters: Non-Invasive Blood Pressures (Systolic, Diastolic and Mean Arterial Pressure), Functional Oxygen Saturation (%SP 0 2), Peripheral Pulse Rate (PPR), Pulse Strength, Oral Temperature and Patient Weight via an external scale. The HomMed Sentry 111B-F Patient Monitor System's optional, compatible devices extend those measurements to glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) monitoring and digital image acquisition. The patient parameter data is collected and displayed by the HomMed Sentry 111B-F Patient Monitor System. Data can be transmitted via the communication module to a central station where the patient data can be viewed and analyzed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040651 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040651: Hommed Sentry Iiib-F Patient Monitor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040651

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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