510(k) · Cleared
ClearedB.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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amzetta Technologies Private Limited · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Aug 28, 2019 as substantially equivalent to K133125 (Withings, 2014) and 4 other predicates after a 358-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Aug 28, 2019
- Review
- 358 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K001670 (2000). 28 ancestors in all, the oldest K001085 (2000). No later device cites it as a predicate yet.
- Root · 9 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 5 generations between
- 3 generations backK102939 Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011
- 2 generations backK120672 KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- 1 generation backK133125 Withings Blood Presure MonitorWithings · 2014 · Recalled
- This deviceK182401 B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff…Amzetta Technologies Private Limited · 2019
Show all 9 generations
- Root · 9 generations backK001670 Automatic Blood Pressure Monitor with Intellisense, Model Hem-757Omron Healthcare, Inc. · 2000
- 8 generations backK030358 KD-622 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2003
- 7 generations backK070828 KD-595 Fully Automatic Electronic Blood Pressure MonitorKodon (Tianjin)Electronic&Electrical Apparatus Co., · 2007
- 6 generations backK080319 KD-591 Fully Automatic Electronic Blood Pressure MonitorAndon Health Co, Ltd. · 2008
- 5 generations backK090963 Fully Automatic Electronic Blood Pressure Monitor, Model KD-556Andon Health Co, Ltd. · 2009
- 4 generations backK101950 Fully Automatic Electronic Blood Pressure Monitor Model KD-930Andon Health Co, Ltd. · 2010
- 3 generations backK102939 Fully Automatic Electronic Blood Pressure Monitor Model KD-931Andon Health Co, Ltd. · 2011
- 2 generations backK120672 KD-936 Fully Automatic Wireless Blood Pressure MonitorAndon Health Co, Ltd. · 2012
- 1 generation backK133125 Withings Blood Presure MonitorWithings · 2014 · Recalled
- This deviceK182401 B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff…Amzetta Technologies Private Limited · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001670 | Automatic Blood Pressure Monitor with Intellisense, Model Hem-757 | Omron Healthcare, Inc. | 2000 | — |
| −8 | K030358 | KD-622 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2003 | — |
| −7 | K070828 | KD-595 Fully Automatic Electronic Blood Pressure Monitor | Kodon (Tianjin)Electronic&Electrical Apparatus Co., | 2007 | — |
| −6 | K080319 | KD-591 Fully Automatic Electronic Blood Pressure Monitor | Andon Health Co, Ltd. | 2008 | — |
| −5 | K090963 | Fully Automatic Electronic Blood Pressure Monitor, Model KD-556 | Andon Health Co, Ltd. | 2009 | — |
| −4 | K101950 | Fully Automatic Electronic Blood Pressure Monitor Model KD-930 | Andon Health Co, Ltd. | 2010 | — |
| −3 | K102939 | Fully Automatic Electronic Blood Pressure Monitor Model KD-931 | Andon Health Co, Ltd. | 2011 | — |
| −2 | K120672 | KD-936 Fully Automatic Wireless Blood Pressure Monitor | Andon Health Co, Ltd. | 2012 | — |
| −1 | K133125 | Withings Blood Presure Monitor | Withings | 2014 | 1 |
| 0 (this device) | K182401 | B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T… | Amzetta Technologies Private Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K133125 | Withings Blood Presure MonitorSummary page 9…ator. Substantial Equivalence comparison of the B.O.L.T NIBP with predicate Devices: The B.O.L.T NIBP model VA01- 0 is compared against the following predicate devices: K133125 Withings Blood Pressure Monitor, Upper Arm Type: BP-801 model BP01 from Withings K120672 Blood Health BPS Fully Automatic Arm Cuf… | 2014 |
| * | K120672 | KD-936 Fully Automatic Wireless Blood Pressure MonitorSummary page 9…B.O.L.T NIBP model VA01- 0 is compared against the following predicate devices: K133125 Withings Blood Pressure Monitor, Upper Arm Type: BP-801 model BP01 from Withings K120672 Blood Health BPS Fully Automatic Arm Cuff Wireless Blood Pressure dock model KD 936 from Andon Health Comparison Item… | 2012 |
| * | K170219 | Microlife Digital Infrared Ear ThermometerSummary page 11…tly in distribution. Substantial Equivalence comparison of the B.O.L.T IRT Thermometer with predicate Devices: B.O.L.T IRT Thermometer model VA01-1 is compared against K170219 Microlife Digital Infrared Ear Thermometer model IR1DR1-1 from Microlife Intellectual Property GmbH, Switzerland Comparison It… | 2017 |
| * | K163135 | Finger Pulse OximeterSummary page 13…ntial Equivalence Comparison B.O.L.T Pulse Oximeter with Predicate Devices: The B.O.L.T Pulse Oximeter model VA01-2 is compared with the following 510K approved devices: K163135 – Fingertip Pulse Oximeter model A330, A310 from Shenzhen Fitfaith Technology Co.,Ltd K140582 – Fingertip Pulse Oximeter JPD-500A… | 2017 |
| * | K140582 | Fingertip Pulse OximeterSummary page 13…Oximeter model VA01-2 is compared with the following 510K approved devices: K163135 – Fingertip Pulse Oximeter model A330, A310 from Shenzhen Fitfaith Technology Co.,Ltd K140582 – Fingertip Pulse Oximeter JPD-500A from Shenzhen Jumper Medical Equipment Co.,Ltd Comparison Item Submitted proposed… | 2014 |
| † | K032305 | Omron Intellisense Digital Blood Pressure Monitor, Model Hem-907XL | 2004 |
| † | K031928 | Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt… | 2003 |
| † | K172861 | Digital thermometer (with disposable thermometer cover) | 2017 |
| † | K082641 | Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DL | 2008 |
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 19 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 28 ancestors has a recall of any class.
- 1 other device also cites its predicate K133125.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
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) *…
Read the full statement (285 words)
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.
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/K182401 · printed Nov 5, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182401
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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