Data / Medical devices / United States / Trividia Health, Inc.
Trividia Health, Inc.: FDA-registered device maker in Fort Lauderdale, FL, United States, 13 510(k) clearances
Trividia Health, Inc. is registered with the FDA (registration 1000113657) in Fort Lauderdale, FL, United States. It lists 10 device types. The FDA files 13 510(k) clearances under its listings, the newest dated July 23, 2026. 6 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000113657
- Address
- 2400 NW 55TH CT, Fort Lauderdale, FL, United States, 33309
- Owner or operator
- TRIVIDIA HEALTH, INC. (9000560)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 19, 1996
- Registered through
- 2026
- Brand names listed
- CVS, Gentle Draw, Good Neighbor Pharmacy, HealthMart, Kroger, Lancets, Lancing Device, Leader 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 |
|---|---|---|---|---|---|---|
| July 23, 2026 | K262116 | TRUE METRIX Self Monitoring Blood Glucose System | NBW | Substantially Equivalent | Trividia Health, Inc. | accessdata.fda.gov |
| December 1, 2023 | K231476 | TRUENESS AIR Blood Glucose Monitoring System; TRUENESS Blood Glucose Monitoring System | NBW | Substantially Equivalent | Sinocare, Inc. | accessdata.fda.gov |
| October 18, 2022 | K221072 | TRUEdraw Lancing Device, Mini Lancing Device | QRL | Substantially Equivalent | Trividia Health | 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 |
| May 19, 2022 | K220370 | Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) | FMK | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| June 27, 2018 | K180720 | Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel | FMI | Substantially Equivalent | Medibio USA, LLC | accessdata.fda.gov |
| April 1, 2016 | K143548 | TRUE METRIX GO Self Monitoring Blood Glucose System | NBW | Substantially Equivalent | Trividia Health, Inc. | accessdata.fda.gov |
| March 26, 2015 | K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System | NBW | Substantially Equivalent | Nipro Diagnostics, Inc. | accessdata.fda.gov |
| August 1, 2014 | K140100 | TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM | NBW | Substantially Equivalent | Nipro Diagnostics, Inc. | accessdata.fda.gov |
| October 17, 2013 | K131013 | FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Nova Biomedical Corporation | accessdata.fda.gov |
| May 7, 2007 | K070593 | TRACKRECORD DATA MANAGEMENT SOFTWARE | NBW | Substantially Equivalent | Home Diagnostics, Inc. | accessdata.fda.gov |
| March 25, 2004 | K040670 | MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL | NBW | Substantially Equivalent | Home Diagnostics, Inc. | accessdata.fda.gov |
| February 25, 2000 | K993017 | PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE | FMF | Substantially Equivalent | Shinchang Medical Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 6, 2026 | 98317 | Class I | Ongoing | Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Mete | The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the app | accessdata.fda.gov |
| October 7, 2025 | 97747 | Class II | Ongoing | Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01. | Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management. | accessdata.fda.gov |
| April 20, 2020 | 85535 | Class II | Terminated | TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. | One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a TRUE METRIX blood glucose meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. | accessdata.fda.gov |
| June 28, 2016 | 74805 | Class II | Ongoing | TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Qua | Product gives incorrect low blood glucose levels. | accessdata.fda.gov |
| October 2, 2013 | 67152 | Class II | Terminated | MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantita | Manufactured with an incorrect factory set unit of measure. | accessdata.fda.gov |
| February 25, 2013 | 64499 | Class II | Terminated | Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The | Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range. | accessdata.fda.gov |
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Updated July 23, 2026. 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.