Data / Medical devices / United States / Fondcircle Inc.
Fondcircle Inc.: FDA-registered device maker in Newport Beach, CA, United States, 14 510(k) clearances
Fondcircle Inc. is registered with the FDA (registration 3034603279) in Newport Beach, CA, United States. It lists 11 device types. The FDA files 14 510(k) clearances under its listings, the newest dated November 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3034603279
- Address
- 4695 MacArthur Court 11th Floor, Newport Beach, CA, United States, 92660
- Owner or operator
- FondCircle Inc. (10092209)
- Roles
- Specification developer
- First device listed
- April 14, 2025
- Registered through
- 2026
- Brand names listed
- FondCircle Arm Blood Pressure Monitor FBP-U1, FondCircle Blood Glucose Meter M1, FondCircle Blood Glucose Monitoring System FBG-M2, FondCircle Blood Glucose Monitoring System Kit FBG-M1, FondCircle Blood Glucose Test Strips M1-S50, FondCircle Blood Glucose Test Strips- VGS01, FondCircle Blood Pressure Monitor FBP-A1, FondCircle Blood Pressure Monitor FBP-A2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Specification developer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Specification developer | accessdata.fda.gov |
| Meter, Peak Flow, Spirometry | BZH | 2 | Specification developer | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Specification developer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Specification developer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Specification developer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Specification developer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| 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 |
| July 1, 2024 | K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) | DQA | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 29, 2024 | K240102 | Blood Pressure Monitor (TMB-2287-B) | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| February 23, 2024 | K230423 | Electronic Peak Flow Meter | BZH | Substantially Equivalent | Taian Dalu Medical Instrument Co., Ltd. | accessdata.fda.gov |
| December 20, 2023 | K233130 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| October 14, 2023 | K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | FLL | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 26, 2023 | K222994 | Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | 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 |
| 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 | K213485 | Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E | FLL | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 20, 2020 | K191657 | Bioland Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bioland Technology, 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 |
| May 30, 2017 | K170954 | Portable ECG Monitor | DPS | Substantially Equivalent | Contec Medical Systems Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Meter, Peak Flow, Spirometry
- All makers of Oximeter
- All makers of Analyzer, Body Composition, Exempt
- All makers of Otoscope
Updated November 15, 2024. 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.