510(k) · Cleared
ClearedHommed Sentry Iii Patient Monitor System with Card Reader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hommed, LLC · DQA Oximeter
Cleared on Apr 9, 2002 after a 124-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.
- Decided
- Apr 9, 2002
- Review
- 124 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK014025 Hommed Sentry Iii Patient Monitor System with Card ReaderHommed, LLC · 2002
- Descendant · cites it directly · 17 of its ownK030797 S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap…Resmed Corp · 2004
- Descendant · 2 generations on · 16 of its ownK051314 Res Traxx Data CenterResmed, Ltd. · 2005
- Descendant · 3 generations on · 15 of its ownK053205 Res Traxx Data CenterResmed, Ltd. · 2006
- Descendant · 4 generations on · 14 of its ownK070746 Restraxx Data Centre, Model R10Resmed, Ltd. · 2007
- Descendant · 5 generations on · 13 of its ownK083816 Res Traxx Online, Model: R14Resmed, Ltd. · 2009
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K030797S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with Somnotraxx…Resmed Corp · 2004 · cites it directly17descendants
- K051314Res Traxx Data CenterResmed, Ltd. · 2005 · 2 generations on16descendants
- K053205Res Traxx Data CenterResmed, Ltd. · 2006 · 3 generations on15descendants
- K070746Restraxx Data Centre, Model R10Resmed, Ltd. · 2007 · 4 generations on14descendants
- K083816Res Traxx Online, Model: R14Resmed, Ltd. · 2009 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014025 | Hommed Sentry Iii Patient Monitor System with Card Reader | Hommed, LLC | 2002 | — |
| +1 | K030797 | S7 Elite Cpap System with Somnotraxx System; Autoset Spirit Cpap System with… | Resmed Corp | 2004 | — |
| +2 | K051314 | Res Traxx Data Center | Resmed, Ltd. | 2005 | — |
| +3 | K053205 | Res Traxx Data Center | Resmed, Ltd. | 2006 | — |
| +4 | K070746 | Restraxx Data Centre, Model R10 | Resmed, Ltd. | 2007 | — |
| +5 | K083816 | Res Traxx Online, Model: R14 | Resmed, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | — | HomMed Sentry III Patient Monitor System Named without a submission number |
What descends from it? (21)
See all 212 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K030797 (Resmed Corp, 2004) has gone furthest, with 17 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The HomMed Sentry III Patient Monitor System with Card Reader is designed to measure Patient Vital Signs in the home by patients or in clinical environments by health care providers. The HomMed Sentry III Patient Monitor System with Card Reader is available with physicians’ orders only. The HomMed Sentry III Patient Monitor System with Card Reader allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor.…
Read the full statement (177 words)
The HomMed Sentry III Patient Monitor System with Card Reader is designed to measure Patient Vital Signs in the home by patients or in clinical environments by health care providers. The HomMed Sentry III Patient Monitor System with Card Reader is available with physicians’ orders only. The HomMed Sentry III Patient Monitor System with Card Reader allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor.
The HomMed Sentry III Patient Monitor System with Card Reader measures the following parameters: Non-Invasive Blood Pressures (Systolic, Diastolic and Mean Arterial Pressure), Functional Oxygen Saturation (%SpO2), Peripheral Pulse Rate (PPR), Pulse Strength, Oral Temperature and Patient Weight via an external scale. The HomMed Sentry III Patient Monitor System with Card Reader’s optional, compatible devices extends those measurements to glucometer and spirometer monitoring. The patient parameter data is collected and displayed by the HomMed Sentry III Patient Monitor System with Card Reader. Data can be transmitted via the communication module to a central station where the patient data can be viewed and analyzed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014025: Hommed Sentry Iii Patient Monitor System with Card Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014025
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026