510(k) · Cleared
ClearedBioTracker 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Jun 26, 2026 as substantially equivalent to K200141 (Ld Technology, LLC, 2020) and 1 other predicate after a 270-day review. Its family tree reaches back 9 generations to 1991.
- Decided
- Jun 26, 2026
- Review
- 270 days
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K903134 (1991). 40 ancestors in all, the oldest K853124 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 5 generations between
- 3 generations backK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008
- 2 generations backK112845 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2011
- 1 generation backK171937 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2018
- This deviceK253306 BioTracker 2.0Biotracker, LLC · 2026
Show all 9 generations
- Root · 9 generations backK903134 Omron Auto Oscillometric Dig BP Mont/Hem-704C 705COmron Marshall Products, Inc. · 1991
- 8 generations backK970211 Microlife Automatic Blood Pressure MonitorMicro Weiss Electronics · 1998
- 7 generations backK013485 Microlife Upper Arm Automatic Blood Pressure Monitor, Model…Microlife Corp. · 2002
- 6 generations backK041411 Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004
- 5 generations backK060686 Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PCMicrolife Intellectual Property GmbH · 2006
- 4 generations backK073198 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Intellectual Property GmbH · 2008
- 3 generations backK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008
- 2 generations backK112845 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2011
- 1 generation backK171937 Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH · 2018
- This deviceK253306 BioTracker 2.0Biotracker, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K903134 | Omron Auto Oscillometric Dig BP Mont/Hem-704C 705C | Omron Marshall Products, Inc. | 1991 | — |
| −8 | K970211 | Microlife Automatic Blood Pressure Monitor | Micro Weiss Electronics | 1998 | — |
| −7 | K013485 | Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with… | Microlife Corp. | 2002 | — |
| −6 | K041411 | Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP | Microlife Corp. | 2004 | — |
| −5 | K060686 | Microlife Automatic Blood Pressure Monitor, Model BP3AC1-1PC | Microlife Intellectual Property GmbH | 2006 | — |
| −4 | K073198 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| −3 | K082357 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp… | Microlife Intellectual Property GmbH | 2008 | — |
| −2 | K112845 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2011 | — |
| −1 | K171937 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | 2018 | — |
| 0 (this device) | K253306 | BioTracker 2.0 | Biotracker, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 this category? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K200141 | Oxi-W SystemSummary page 6…Cardiovascular Primary Predicate Device Predicate Device: Oxi-W System Sponsor LD Technology, LLC 510(K) K200141 Regulation Number: 21 CFR 870.2300, Regulation Name: Cardiac Monitor (including cardiotachometer and rate… | 2020 |
| * | K171937 | Microlife Upper Arm Automatic Digital Blood Pressure MonitorSummary page 6…Monitor, WatchBP Office Central (TWIN200 CBP) Sponsor Microlife Intellectual Property GmbH 510(K) K171937 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System — Micro… | 2018 |
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 5 companies; a new generation was cleared every 3.1 years on median.
- None of the 40 ancestors has a recall.
What is it indicated for?
BioTracker 2.0 is software intended to acquire, display, store, organize, and report physiological data obtained from compatible legally marketed physiological acquisition devices for review by licensed healthcare professionals. The software acquires physiological measurements including oxygen saturation (SpO₂), pulse rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure (MAP). The software performs mathematical analysis of…
Read the full statement (255 words)
BioTracker 2.0 is software intended to acquire, display, store, organize, and report physiological data obtained from compatible legally marketed physiological acquisition devices for review by licensed healthcare professionals.
The software acquires physiological measurements including oxygen saturation (SpO₂), pulse rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure (MAP).
The software performs mathematical analysis of the acquired physiological measurements and derived pulse waveform data to calculate the following parameters:
• Ankle-Brachial Index (ABI) (right and left)
• Root Mean Square of Successive Differences (RMSSD)
• Standard Deviation of Normal-to-Normal Intervals (SDNN)
• Percentage of Successive NN Intervals Differing by More Than 50 ms (pNN50)
• Low Frequency/High Frequency Ratio (LF/HF)
• Reflection Index (RI)
• Pulse Wave Amplitude Ratio (PWAR)
• Stiffness Index (SI)
Each calculated parameter is displayed individually together with its corresponding unit of measure. BioTracker 2.0 performs mathematical analysis and presentation of physiological data only. The software does not provide diagnostic interpretations, disease classification, patient risk scores, comparative indicators, alarms, treatment recommendations, or aggregated clinical assessments. Interpretation of the reported physiological measurements and calculated parameters is the responsibility of the licensed healthcare professional.
BioTracker 2.0 is intended for spot-check physiological assessments only. It is not intended for continuous physiological monitoring, real-time patient monitoring, life-support applications, or physiological alarm generation.
BioTracker 2.0 is intended for use in primary care practices, family medicine practices, internal medicine practices, outpatient physician offices, and outpatient healthcare clinics.
BioTracker 2.0 is intended for use by licensed healthcare professionals on adult patients 18 years of age or older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253306: BioTracker 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253306
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026