510(k) · Cleared
ClearedOmron Automatic Blood Pressure Monitor with Intellisense, Models Hem-773, Hem-773AC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Dec 12, 2002 after a 204-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Dec 12, 2002
- Review
- 204 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK021682 Omron Automatic Blood Pressure Monitor with Intellisense, Models…Omron Healthcare, Inc. · 2002
- Descendant · cites it directly · 5 of its ownK060504 Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001Ideal Life, Inc. · 2006
- Descendant · 2 generations on · 4 of its ownK080538 Ideal Life Pod (Model Ilp 0001)Ideal Life, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK041313 Stabil-O-GraphI.E.M. GmbH · 2004
- Descendant · 3 generations on · 2 of its ownK111932 Iglucose SystemPositiveid Corporation · 2011
- Descendant · 4 generations on · 1 of its ownK130676 Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K060504Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001Ideal Life, Inc. · 2006 · cites it directly5descendants
- K080538Ideal Life Pod (Model Ilp 0001)Ideal Life, Inc. · 2008 · 2 generations on4descendants
- K041313Stabil-O-GraphI.E.M. GmbH · 2004 · cites it directly3descendants
- K111932Iglucose SystemPositiveid Corporation · 2011 · 3 generations on2descendants
- K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health · 2013 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021682 | Omron Automatic Blood Pressure Monitor with Intellisense, Models Hem-773… | Omron Healthcare, Inc. | 2002 | — |
| +1 | K060504 | Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001 | Ideal Life, Inc. | 2006 | — |
| +2 | K080538 | Ideal Life Pod (Model Ilp 0001) | Ideal Life, Inc. | 2008 | — |
| +1 | K041313 | Stabil-O-Graph | I.E.M. GmbH | 2004 | — |
| +3 | K111932 | Iglucose System | Positiveid Corporation | 2011 | — |
| +4 | K130676 | Ambio Remote Health Monitoring System | Arrayent Health, LLC D/B/A Ambio Health | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
2 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, K060504 (Ideal Life, Inc., 2006) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DXN devicesDXN 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 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 device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 incties to 17 inches (from 22 cm to 42 cm).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021682: Omron Automatic Blood Pressure Monitor with Intellisense, Models Hem-773, Hem-773AC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021682
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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