510(k) · Cleared
ClearedBP Limbo XL, Bptango XL, BP Salsa XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datadancer Medical Systems · DQK Computer, Diagnostic, Programmable
Cleared on Oct 31, 2008 as substantially equivalent to K060686 (Microlife Intellectual Property GmbH, 2006) and 1 other predicate after a 400-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Oct 31, 2008
- Review
- 400 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K903134 (1991). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 4 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 3 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 2 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 1 generation backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- This deviceK072752 BP Limbo XL, Bptango XL, BP Salsa XLDatadancer Medical Systems · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −4 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −3 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −2 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −1 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| 0 (this device) | K072752 | BP Limbo XL, Bptango XL, BP Salsa XL | Datadancer Medical Systems | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 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 26.6 · 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 |
|---|---|---|---|
| * | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCSummary page 1…DQK 3. Predicate Devices: Microlife Automated Blood Pressure Monitor with personal computer software Model: BP3AC1-1PC 510(k) Number: K060686 Panasonic Wrist Blood Pressure Monitor Model: EW3037 510(k) Number: K042818 4. Device Descriptions:… | 2006 |
| * | K042818 | Panasonic Wrist Blood Pressure Monitor, Models EW3003 and EW3037Summary page 1…tware Model: BP3AC1-1PC 510(k) Number: K060686 Panasonic Wrist Blood Pressure Monitor Model: EW3037 510(k) Number: K042818 4. Device Descriptions: 4.1 bp Limbo XL DataDancer Blood Pressure (bp) Log Software, Model "bp Limbo XL", is a Microsoft Excel… | 2005 |
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 17 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 7 ancestors has a recall.
- 3 other devices also cite its predicate K060686.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
bp Limbo XL, bp Salsa XL and bp Tango XL are designed for Adult Blood Pressure Only or persons 18 years or older. bp Limbo XL, bp Salsa XL and bp Tango XL are intended to be used as a personal blood pressure log to record patient measured results from a personal blood pressure monitor aiding in the management of hypertension as directed by a patient's physician or health care provider. The printed reports, and subsequent information contained within, are…
Read the full statement (145 words)
bp Limbo XL, bp Salsa XL and bp Tango XL are designed for Adult Blood Pressure Only or persons 18 years or older.
bp Limbo XL, bp Salsa XL and bp Tango XL are intended to be used as a personal blood pressure log to record patient measured results from a personal blood pressure monitor aiding in the management of hypertension as directed by a patient's physician or health care provider. The printed reports, and subsequent information contained within, are intended for review and interpretation by a physician and not as a stand alone diagnostic tool.
If bp Limbo XL, bp Salsa XL or bp Tango XL are used without a physician or health care provider relationship, all information must be considered educational, relating to the user's condition, and not as medical advice for the purpose of diagnosis, administration of treatment(s) or to prescribe medication(s).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072752: BP Limbo XL, Bptango XL, BP Salsa XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072752
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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