510(k) · Cleared

Cleared

Sentry Otc Monitor

K061088510(k) TraditionalCleared Jun 9, 200652-day reviewClass II21 CFR 870.2910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Honeywell Hommed, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Jun 9, 2006 as substantially equivalent to K040651 (Hommed, LLC, 2004) after a 52-day review. Its family tree reaches back 2 generations to 2002.

Decided: Jun 9, 2006
Review: 52 days
Class: Class II
Product code: DRG
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K014025 (2002). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK014025 Hommed Sentry Iii Patient Monitor System with Card ReaderHommed, LLC · 2002
1 generation backK040651 Hommed Sentry Iiib-F Patient Monitor SystemHommed, LLC · 2004
This deviceK061088 Sentry Otc MonitorHoneywell Hommed, LLC · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K014025	Hommed Sentry Iii Patient Monitor System with Card Reader	Hommed, LLC	2002	—
−1	K040651	Hommed Sentry Iiib-F Patient Monitor System	Hommed, LLC	2004	—
0 (this device)	K061088	Sentry Otc Monitor	Honeywell Hommed, LLC	2006	—

FIG. 1 — Lineage of K061088, 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 DRG? 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 DRG device

#1 K223711 ANNE Onescore 20.8 · 11 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
*	K040651	Hommed Sentry Iiib-F Patient Monitor System Summary page 1 …iovascular and Respiratory Devices, Class II Product Code: NIBP Measurement System, DXN Predicate Device: HomMed Sentry IIIB Patient Monitor System K040651 Device Description: The Honeywell HomMed Sentry OTC Monitor is a vital signs monitoring system.…	Hommed, LLC	2004	—

Also cleared against K040651: 1 other device →

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?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K040651.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRG

3in 2025

2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007high 287 (2022) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRG

3in 2007

2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRG

52in 2025

2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, 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	6	63	3	14
2008	5	74	0	9
2009	13	94	0	5
2010	10	68	0	13
2011	9	104	0	12
2012	12	103	0	9
2013	13	146	0	13
2014	10	177	0	97
2015	2	—	0	131
2016	2	—	0	182
2017	7	98	0	484
2018	6	220	0	166
2019	5	122	0	70
2020	6	159	0	82
2021	2	—	0	107
2022	6	287	0	43
2023	4	212	0	19
2024	3	125	0	26
2025	3	127	0	52
2026	2	—	1	—

What is it indicated for?

The Honeywell HomMed Sentry OTC Monitor is designed to retrospectively monitor vital signs. Vital signs include noninvasive blood pressure, pulse rate, oral temperature and weight. Data from optional commercial stand-alone products extend the Sentry OTC Monitor's measurement capabilities. Data from the Sentry OTC Monitor can be transmitted via a communication module to a central viewing station for display. The Sentry OTC Monitor is not intended for emergency use or real-time monitoring.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061088 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061088: Sentry Otc Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061088

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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