Data / Medical devices / United States / I-Sens Usa, Inc.
I-Sens Usa, Inc.: FDA-registered device maker in Torrance, CA, United States, 15 510(k) clearances
I-Sens Usa, Inc. is registered with the FDA (registration 3008780388) in Torrance, CA, United States. It lists 9 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 6, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008780388
- Address
- 3545 Lomita Blvd., Unit D, Torrance, CA, United States, 90505
- Owner or operator
- i-SENS USA, Inc. (10034826)
- Roles
- Complaint file establishment
- First device listed
- January 9, 2022
- Registered through
- 2026
- Brand names listed
- CS Tianjin Lancet Multiple Use, CS Tianjin Lancet Single use, CareSens N Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System, CareSens N Feliz Blood Glucose Monitoring System, CareSens N POP Blood Glucose Monitoring System, CareSens N Plus BT Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Complaint file establishment | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Complaint file establishment | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Complaint file establishment | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Complaint file establishment | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| May 25, 2022 | K210748 | Well-life TM Pen Needles, Well-life TM Safety Pen Needles | FMI | Substantially Equivalent | W. L. Med Co., Ltd. | accessdata.fda.gov |
| October 5, 2021 | K201394 | CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| September 9, 2020 | K201551 | KetoSens BT Blood B-Ketone Monitoring System | JIN | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| January 24, 2020 | K192859 | CareSens S Clear BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| January 17, 2020 | K193590 | CareSens S Fit BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| August 31, 2018 | K180866 | CareSens S Fit Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| April 13, 2018 | K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | JIN | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| December 13, 2017 | K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| October 19, 2017 | K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| December 16, 2016 | K160742 | NoCoding1 Plus Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| June 19, 2013 | K131395 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| July 10, 2012 | K121133 | CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| May 3, 2012 | K120351 | CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| February 10, 2009 | K083468 | CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
- All makers of Glucose Oxidase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Updated July 6, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.