Data / Medical devices / United States / Prodigy Diabetes Care, LLC
Prodigy Diabetes Care, LLC: FDA-registered device maker in Huntersville, NC, United States, 17 510(k) clearances
Prodigy Diabetes Care, LLC is registered with the FDA (registration 3008789114) in Huntersville, NC, United States. It lists 12 device types. The FDA files 17 510(k) clearances under its listings, the newest dated February 10, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008789114
- Address
- 11621 Patterson Road Suite 230, Huntersville, NC, United States, 28078
- Owner or operator
- Prodigy Diabetes Care, LLC (10033726)
- Roles
- Complaint file establishment
- First device listed
- April 28, 2011
- Registered through
- 2026
- Brand names listed
- Count A Dose, DDI Ultrasonic Nebulizer System, OKB OTC hearing aid GV-SA3.60, PRODIGY Astro Blood Glucose Monitoring System, PRODIGY Astro PRO Blood Glucose Monitoring System, PRODIGY Astro PRO Blood Glucose Test Strips, Prodigy Adjustable Depth Lancing Device, Prodigy AutoCode Blood Glucose Monitoring System and more
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 |
|---|---|---|---|---|---|---|
| February 10, 2023 | K223208 | Safety Lancet | FMK | Substantially Equivalent | Suzhou Zhenwu Medical Co., Ltd. | accessdata.fda.gov |
| November 30, 2022 | K222472 | Lancing System, Sterile Lancet for Single Use, Lancing Device | QRL | Substantially Equivalent | Shandong Lianfa Medical Plastic Products Co. , Ltd. | accessdata.fda.gov |
| 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 |
| July 20, 2016 | K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | NBW | Substantially Equivalent | Ok Biotech 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 17, 2015 | K142785 | PRODIGY iConnect Blood Glucose Monitoring System | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
| August 14, 2014 | K132633 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
| November 26, 2013 | K122340 | PRODIGY CHOICE | NBW | Substantially Equivalent | Prodigy Diabetes Care, LLC | accessdata.fda.gov |
| November 5, 2013 | K122338 | PREFERRED BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Prodigy Diabetes Care, LLC | accessdata.fda.gov |
| December 14, 2011 | K112057 | KDL SYRINGES AND NEEDLE | FMF | Substantially Equivalent | Shanghai Kindly Enterprise Dev. Group Co., | accessdata.fda.gov |
| October 12, 2011 | K103115 | PRODIGY DIABETES MANAGEMENT SOFTWARE | NBW | Substantially Equivalent | Prodigy Diabetes Care, LLC | accessdata.fda.gov |
| February 4, 2010 | K090609 | OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
| June 18, 2009 | K090307 | DDI ULTRASONIC NEBULIZER SYSTEM | CAF | Substantially Equivalent | Diagnostic Devices, Inc. | accessdata.fda.gov |
| March 5, 2008 | K073118 | PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Diagnostic Devices, Inc. | accessdata.fda.gov |
| February 9, 2007 | K063026 | OK METER BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
| July 13, 2006 | K060467 | PRODIGY BLOOD GLUCOSE TEST SYSTEM | NBW | Substantially Equivalent | Diagnostic Devices, Inc. | accessdata.fda.gov |
| September 15, 1988 | K883311 | COUNT-A-DOSE | FMF | Substantially Equivalent | Pavel Jordan & Associates, Inc. | accessdata.fda.gov |
Compare with other makers
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Updated February 10, 2023. 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.