Data / Medical devices / United States / Veridian Healthcare
Veridian Healthcare: FDA-registered device maker in Gurnee, IL, United States, 19 510(k) clearances
Veridian Healthcare is registered with the FDA (registration 3007499349) in Gurnee, IL, United States. It lists 16 device types. The FDA files 19 510(k) clearances under its listings, the newest dated April 1, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007499349
- FEI number
- 3011774813
- Address
- 1175 Lakeside Dr, Gurnee, IL, United States, 60031
- Owner or operator
- Veridian Healthcare (10028759)
- Roles
- Repackager or relabeler
- First device listed
- September 6, 2023
- Registered through
- 2026
- Brand names listed
- 01-508 SmartHeart Automatic Wrist Digital BP, 01-517 SmartHeart Automatic Wrist Blood Pressure Monitor with Large Display, 01-539 SmartHeart Auto Digital Blood Pressure Monitor, 01-539WR SmartHeart Auto Digital BP Monitor, Wide Range Cuff, 01-540 SmartHeart Wrist Blood Pressure Monitor, 01-550 SmartHeart Automatic Arm Digital BP, 01-553 SmartHeart Automatic DBPM-Wide Range Cuff, 01-556 SmartHeart Automatic Wrist Digital BP 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 |
|---|---|---|---|---|---|---|
| April 1, 2026 | K260276 | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 2, 2025 | K250161 | Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 30, 2025 | K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 15, 2024 | K243306 | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-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, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| August 21, 2024 | K241351 | Blood Pressure Monitor (TMB-2092-G) | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| December 20, 2023 | K233130 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| November 28, 2023 | K232713 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| June 28, 2023 | K223722 | MIO Blood Glucose Monitoring System | NBW | Substantially Equivalent | Mio Labs, Inc. | accessdata.fda.gov |
| December 1, 2022 | K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 19, 2018 | K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System | NBW | Substantially Equivalent | Vivachek Laboratories, Inc. | accessdata.fda.gov |
| February 10, 2012 | K112042 | KINGYIELD WRIST BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Shenzhen Kingyield Technology Co., Ltd. | accessdata.fda.gov |
| January 31, 2012 | K120058 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| December 16, 2010 | K102624 | AVITA WRIST TYPE BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Avita Corporation | accessdata.fda.gov |
| November 24, 2010 | K102690 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
| October 29, 2010 | K102906 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
| November 10, 2009 | K091272 | BESMED JET NEBULIZER BOTTLE SET | CAF | Substantially Equivalent | Besmed Health Business Corp | accessdata.fda.gov |
| July 30, 2009 | K092045 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 | DXN | Substantially Equivalent | Andon Health Co, Ltd. | accessdata.fda.gov |
| March 23, 2007 | K062033 | BP 101 DIGITAL BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Kingyield Hongkong Limited | accessdata.fda.gov |
| January 14, 2000 | K984551 | INFRARED EAR THERMOMETER, MODEL KI-8120 | FLL | Substantially Equivalent | K-Jump Health Co., Ltd. | accessdata.fda.gov |
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Updated April 1, 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.