510(k) · Cleared
ClearedHolter ECG and ABP system (HolterABP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Feb 9, 2026 as substantially equivalent to K151787 (Edan Instruments, Inc., 2016) and 1 other predicate after a 262-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Feb 9, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K903134 (1991). 102 ancestors in all, the oldest K843503 (1984). No later device cites it as a predicate yet.
- Root · 10 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 6 generations between
- 3 generations backK122129 Sphygmocor XcelAtcor Medical · 2012
- 2 generations backK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled
- 1 generation backK210139 Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06…Edan Instruments, Inc. · 2021
- This deviceK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 9 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 8 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 7 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 6 generations backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- 5 generations backK081590 YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600…Ya Horng Electronic Co., Ltd. · 2008
- 4 generations backK083093 Cheetah ReliantCheetah Medical, Inc. · 2008 · Recalled
- 3 generations backK122129 Sphygmocor XcelAtcor Medical · 2012
- 2 generations backK151520 Oscar 2Suntech Medical, Inc. · 2016 · Recalled
- 1 generation backK210139 Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06…Edan Instruments, Inc. · 2021
- This deviceK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −9 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −8 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −7 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −6 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| −5 | K081590 | YA Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R… | Ya Horng Electronic Co., Ltd. | 2008 | — |
| −4 | K083093 | Cheetah Reliant | Cheetah Medical, Inc. | 2008 | 1 |
| −3 | K122129 | Sphygmocor Xcel | Atcor Medical | 2012 | — |
| −2 | K151520 | Oscar 2 | Suntech Medical, Inc. | 2016 | 2 |
| −1 | K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 | Edan Instruments, Inc. | 2021 | — |
| 0 (this device) | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 10 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K151787 | Holter SystemSummary page 5…Regulatory Class: Class II 4. Predicate Device(s): 1) Edan Instruments, Holter System, models SE-2003 and SE-2012, cleared under K151787 2) Edan Instruments, Ambulatory Blood Pressure Monitor, models: SA-10, SA- 05… | 2016 |
| * | K210139 | Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09Summary page 5…2) Edan Instruments, Ambulatory Blood Pressure Monitor, models: SA-10, SA- 05, SA-06, SA-08 and SA-09, cleared under K210139 5. Reason for By submission of the Traditional 510(k), Edan Instruments is requesting cle… | 2021 |
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 35 years and passes through 9 companies; a new generation was cleared every 3.7 years on median.
- 6 of the 102 ancestors have a recall of any class.
- 1 other device also cites its predicate K151787.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The Holter ECG and ABP system is intended to acquire, analyze, display, edit and generate report of ambulatory ECG, ambulatory blood pressure and combined Holter ECG and ABP data. The analysis results are offered to doctors on an advisory basis only. Data acquired may be used for the following indications: · Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. · Evaluation of patients for ST segment changes. · Evaluation of drug response…
Read the full statement (159 words)
The Holter ECG and ABP system is intended to acquire, analyze, display, edit and generate report of ambulatory ECG, ambulatory blood pressure and combined Holter ECG and ABP data. The analysis results are offered to doctors on an advisory basis only.
Data acquired may be used for the following indications:
· Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
· Evaluation of patients for ST segment changes.
· Evaluation of drug response in patients taking anti-arrhythmic medications.
· Evaluation of patients with pacemakers.
The ambulatory blood pressure function is intended for use in patients over 12 years of age from data collected from an FDA cleared ambulatory blood pressure cuff.
The ECG Analysis function is intended for use in adults and pediatric, but arrhythmia detection is intended for use in patients over 12 years of age.
The Holter ECG and ABP system is intended to be used only in hospital and healthcare facilities by physicians or trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251591: Holter ECG and ABP system (HolterABP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251591
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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