510(k) · Cleared
ClearedAccutracker DX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suntech Medical Instruments, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jul 14, 1992 after a 321-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jul 14, 1992
- Review
- 321 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK913844 Accutracker DXSuntech Medical Instruments, Inc. · 1992
- Descendant · cites it directly · 3 of its ownK031964 BpcardQrs Diagnostic, LLC · 2003
- Descendant · 2 generations on · 2 of its ownK073630 Modification to: Bpcard, Model Z-7000-0700Qrs Diagnostic, LLC · 2008
- Descendant · 3 generations on · 1 of its ownK103703 Reguis SigmaKonica Minolta Medical & Graphic, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK120131 Regius SIGMA2Konica Minolta Medical & Graphic, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK051368 BR 102 Plus Blood Pressure Holter SystemSchiller AG · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031964BpcardQrs Diagnostic, LLC · 2003 · cites it directly3descendants
- K073630Modification to: Bpcard, Model Z-7000-0700Qrs Diagnostic, LLC · 2008 · 2 generations on2descendants
- K103703Reguis SigmaKonica Minolta Medical & Graphic, Inc. · 2011 · 3 generations on1descendant
- K120131Regius SIGMA2Konica Minolta Medical & Graphic, Inc. · 2012 · 4 generations on0descendants
- K051368BR 102 Plus Blood Pressure Holter SystemSchiller AG · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913844 | Accutracker DX | Suntech Medical Instruments, Inc. | 1992 | — |
| +1 | K031964 | Bpcard | Qrs Diagnostic, LLC | 2003 | — |
| +2 | K073630 | Modification to: Bpcard, Model Z-7000-0700 | Qrs Diagnostic, LLC | 2008 | — |
| +3 | K103703 | Reguis Sigma | Konica Minolta Medical & Graphic, Inc. | 2011 | — |
| +4 | K120131 | Regius SIGMA2 | Konica Minolta Medical & Graphic, Inc. | 2012 | — |
| +1 | K051368 | BR 102 Plus Blood Pressure Holter System | Schiller AG | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
3 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, K031964 (Qrs Diagnostic, LLC, 2003) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K913844 · printed Nov 5, 2026
Cite this page
510(k) Report. “K913844: Accutracker DX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K913844
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026