# K182401: B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology (IRT) Thermometer probe, B.O.L.T Pulse Oximeter (SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter

- Pathway: 510(k) (Traditional)
- Applicant: Amzetta Technologies Private Limited
- Decided: Aug 28, 2019 after 358 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K001670 (2000). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133125: Withings Blood Presure Monitor, Withings (2014) Summary page 9.
- K120672: KD-936 Fully Automatic Wireless Blood Pressure Monitor, Andon Health Co, Ltd. (2012) Summary page 9.
- K170219: Microlife Digital Infrared Ear Thermometer, Microlife Intellectual Property GmbH (2017) Summary page 11.
- K163135: Finger Pulse Oximeter, Shenzhen Fitfaith Technology Co.,Ltd (2017) Summary page 13.
- K140582: Fingertip Pulse Oximeter, Shenzhen Jumper Medical Equipment Co., Ltd. (2014) Summary page 13.

## Indications for use
B.O.L.T model (VAO1) Base unit with it's accessory devices attachment (VA01-0, VAO1-1 and VA01-2) and the B.O.L.T application is a patient vitals measuring and monitoring system used for spot-checking and measuring the physiological parameters of adult patients / users (18 years of age or older). The physiological parameters measured and monitored are: * Non-Invasive Blood Pressure (NIBP), Pulse Rate (PR) » Oxygen saturation (SpO2), Pulse Rate (PR) * Body Temperature (TEMP) B.O.L.T application is downloaded and installed in a Bluetooth enabled smart devices/ computer. The operations of the base unit and the attached devices like start and stop are controlled by the B.O.L.T application and the results are displayed by the B.O.L.T application on the screen of the smart devices/ computer. This device is applicable for use by an adult and it can be used in a clinical setting like a physician office and also in a home environment for patients to keep track of the physiological parameters mentioned above. Home users are advised to contact their physician if any abnormal values are indicated. B.O.L.T, NIBP model Base unit (VAO1) along with an inflatable cuff (VAO01-0) that is wrapped around the upper arm, is a fully automatic, non-invasive, wireless blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual. B.O.L.T, IRT model Base unit (VA01) along with a thermometer probe (VAO1-1) using infrared sensor detects body temperature from the ear canal in the adult population. B.O.L.T, Pulse Oximeter model Base unit (VAO1) along with a pulse oximeter probe (VAO01-2) is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) from the fingertip of adult users.

Source page: https://510kreport.com/device/K182401
Methodology: https://510kreport.com/methodology