510(k) · Cleared
ClearedStabil-O-Graph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I.E.M. GmbH · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 18, 2004 as substantially equivalent to K021682 (Omron Healthcare, Inc., 2002) after a 32-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.
- Decided
- Jun 18, 2004
- Review
- 32 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021682 (2002). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK021682 Omron Automatic Blood Pressure Monitor with Intellisense, Models…Omron Healthcare, Inc. · 2002
- This deviceK041313 Stabil-O-GraphI.E.M. GmbH · 2004
- Descendant · cites it directly · 1 of its ownK053395 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK173895 Tel-O-GraphI.E.M. Industrielle Entwicklung and Medizintechnik · 2019
- Descendant · 2 generations on · 0 of its ownK060703 PMP4 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd. · 2006
Most influential descendants
Showing 3 of 3 · See all- K053395BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd. · 2005 · cites it directly1descendant
- K173895Tel-O-GraphI.E.M. Industrielle Entwicklung and Medizintechnik · 2019 · cites it directly0descendants
- K060703PMP4 BP Pro Blood Pressure MonitorCard Guard Scientific Survival, Ltd. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021682 | Omron Automatic Blood Pressure Monitor with Intellisense, Models Hem-773… | Omron Healthcare, Inc. | 2002 | — |
| 0 (this device) | K041313 | Stabil-O-Graph | I.E.M. GmbH | 2004 | — |
| +1 | K053395 | BP Pro Blood Pressure Monitor | Card Guard Scientific Survival, Ltd. | 2005 | — |
| +1 | K173895 | Tel-O-Graph | I.E.M. Industrielle Entwicklung and Medizintechnik | 2019 | — |
| +2 | K060703 | PMP4 BP Pro Blood Pressure Monitor | Card Guard Scientific Survival, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K021682 | Omron Automatic Blood Pressure Monitor with Intellisense, Models Hem-773, Hem-773AC Our reading of the summary gave K021862, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “OMRON, Model HEM-711 (773 AC)”. | 2002 |
What descends from it? (3)
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?
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 I.E.M. Stabil-O-Graph is intended to be used by adults at home to monitor
Blood Pressure (systolic and diastolic) and pulse rate from the upper arm with arm
circumference ranging from 9.4 inches to 16.5 inches (24 cm to 42 cm).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041313: Stabil-O-Graph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041313
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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