# K253306: BioTracker 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Biotracker, LLC
- Decided: Jun 26, 2026 after 270 days
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K903134 (1991). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200141: Oxi-W System, Ld Technology, LLC (2020) Summary page 6.
- K171937: Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Microlife Intellectual Property GmbH (2018) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K253306
Methodology: https://510kreport.com/methodology