Data / Medical devices / United States / Care Living Diagnostics Inc
Care Living Diagnostics Inc: FDA-registered device maker in South Setauket, NY, United States, 7 510(k) clearances
Care Living Diagnostics Inc is registered with the FDA (registration 3031259044) in South Setauket, NY, United States. It lists 12 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031259044
- Address
- 43 Sunflower Ridge Rd, South Setauket, NY, United States, 11720
- Owner or operator
- Care Living Diagnostics Inc (10090880)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 27, 2024
- Registered through
- 2026
- Brand names listed
- Astrasono Bladder Scanner A3Pro/A3Pro Lite/A3Essential/A5Pro
Devices it lists
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 |
|---|---|---|---|---|---|---|
| September 30, 2025 | K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | IYO | Substantially Equivalent | Astrasono Technology Co., Ltd. | accessdata.fda.gov |
| October 4, 2024 | K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) | DXN | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
| November 27, 2023 | K230379 | Portable (Ultrasonic) Nebulizer | CAF | Substantially Equivalent | Dongguan Simzo Electronic Technology Co., Ltd. | accessdata.fda.gov |
| September 19, 2022 | K221839 | Lancet | FMK | Substantially Equivalent | Hebei Xinle Sci&Tech Co., Ltd. | accessdata.fda.gov |
| July 1, 2022 | K221176 | Insulin Pen Needle | FMI | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| March 25, 2016 | K152808 | U&U Insulin Syringe with/without Safety Retractable Device | MEG | Substantially Equivalent | U&U Medical Technology Co, Ltd. | accessdata.fda.gov |
| December 9, 2005 | K052208 | GLUCOSE PILOT | NBW | Substantially Equivalent | Tianjin New Bay Bioresearch Co., Ltd. | accessdata.fda.gov |
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Updated September 30, 2025. 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.