510(k) · Cleared
ClearedHEM-9000AI
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 Oct 10, 2008 as substantially equivalent to K050233 (Omron Healthcare, Inc., 2005) and 2 other predicates after a 120-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Oct 10, 2008
- Review
- 120 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K950779 (1995). 20 ancestors in all, the oldest K872291 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK950779 Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
- 4 generations backK972991 Monitor One NDXQmed, Inc. · 1998
- 3 generations backK991831 BMT Anscore Health Management System, Model 1.1Boston Medical Technologies, Inc. · 1999
- 2 generations backK993875 BMT Anscore Health Management SystemBoston Medical Technologies, Inc. · 2000
- 1 generation backK070795 Sphygmocor Cardiovascular Management SystemAtcor Medical Pty, Ltd. · 2007
- This deviceK081654 HEM-9000AIOmron Healthcare, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950779 | Heart Rate Variability Software Option | Spacelabs, Inc. | 1995 | — |
| −4 | K972991 | Monitor One NDX | Qmed, Inc. | 1998 | — |
| −3 | K991831 | BMT Anscore Health Management System, Model 1.1 | Boston Medical Technologies, Inc. | 1999 | — |
| −2 | K993875 | BMT Anscore Health Management System | Boston Medical Technologies, Inc. | 2000 | — |
| −1 | K070795 | Sphygmocor Cardiovascular Management System | Atcor Medical Pty, Ltd. | 2007 | — |
| 0 (this device) | K081654 | HEM-9000AI | Omron Healthcare, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 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 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? (3)
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 |
|---|---|---|---|
| * | K050233 | Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AISummary page 1…DXN - System, Measurement, Blood-pressure, Non-invasive Device: Model - HEM-9000AI-X Predicate Devices: Omron - HEM-9000AI - K050233 AtCor SphygmoCor Px - K012487 AtCor Medical - SphygmoCor CvMS- K0… | 2005 |
| * | K012487 | Sphygmocor PX Model Scor-PXSummary page 1…Device: Model - HEM-9000AI-X Predicate Devices: Omron - HEM-9000AI - K050233 AtCor SphygmoCor Px - K012487 AtCor Medical - SphygmoCor CvMS- K070795 Device Description: The modified HEM-9000AI-X is an osc… | 2002 |
| * | K070795 | Sphygmocor Cardiovascular Management SystemSummary page 1…Omron - HEM-9000AI - K050233 AtCor SphygmoCor Px - K012487 AtCor Medical - SphygmoCor CvMS- K070795 Device Description: The modified HEM-9000AI-X is an oscillometric NIBP measurement device and tonometer Augmentation Index detec… | 2007 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 20 ancestors has a recall.
- 1 other device also cites its predicate K050233.
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. 2008, this device’s year, is highlighted.
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 HEM-9000Ai-X is intended to measure systolic and diastolic blood pressure and pulse rate in adults with an arm circumference of 17 - 50 cm (7-20 inches), and to calculate a radial augmentation index (Al) and central (aortic) blood pressure which is used on adult patients only.
The HEM-9000AI-X is intended for use in physicians' offices, hospitals, clinics and other medical facilities where non-invasive blood pressure and radial Al measurements/calculations are performed on patients and invasive measurement is contraindicated.
The Augmentation Index (Al) function of the HEM-9000AI-X has not been evaluated on patients who have intra-ventricular conduction delays (VCD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081654: HEM-9000AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081654
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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