FONDCIRCLE INC.

FDA Device Registration & Listing · Newport Beach, CA, US · Registration 3034603279

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3034603279
FEI Number
3034603279
Entity Name
FONDCIRCLE INC.
City/State/Country
Newport Beach, CA, US
Establishment Address
4695 MacArthur Court 11th Floor, Newport Beach, CA 92660, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
FondCircle Inc. (Owner Number: 10092209)
Owner / Operator Contact Address
4695 MacArthur Court 11th Floor, Newport Beach, CA 92660, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K230423
PMA Number
N/A

All Registered Proprietary Names

FondCircle Twist Lancet IK FondCircle Multi-Function Smart Otoscope and Oral Camera FMC-N1 FondCircle Ear, Nose & Throat Smart Otoscope-FMC-S1 FondCircle Pulse Oximeter FPO-F1 FondCircle Weight Scale FBF-W1 FondCircle Body Fat Scale FBF-F3 FondCircle Body Fat Scale FBF-F2 FondCircle Body Fat Scale FBF-F4 FondCircle Blood Glucose Test Strips- VGS01 FondCircle Control Solution- VGC01 FondCircle Blood Glucose Monitoring System FBG-M2 FondCircle Blood Glucose Monitoring System Kit FBG-M1 FondCircle Blood Glucose Meter M1 FondCircle Blood Glucose Test Strips M1-S50 FondCircle Blood Pressure Monitor FBP-A2 FondCircle Arm Blood Pressure Monitor FBP-U1 FondCircle Blood Pressure Monitor FBP-A3XL FondCircle Blood Pressure Monitor FBP-A3 FondCircle Digital Thermometer FTM-B1 FondCircle Wrist Blood Pressure Monitor FBP-W1 FondCircle Infrared Thermometer FTM-D1 FondCircle Electronic Peak Flow Meter FPF-S1

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-09-09
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2025-09-09
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2025-09-09
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2025-08-19
DQA Oximeter Cardiovascular Class 2 870.2700 2025-04-14
PUH Analyzer, Body Composition, Exempt Cardiovascular Class 2 870.2770 2025-04-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2025-04-14
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2025-04-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-04-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-04-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-09-09
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-04-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-04-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-04-14
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2025-08-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FondCircle Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K130132 Medipurpose Pte. , Ltd. BABYLANCE HEEL INCISION DEVICE 2013-02-11
K932506 Rudolf Riester GmbH & Co. KG RI-SCOPE (S) 1993-10-08
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0044-2008 Becton Dickinson & Company 2
Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034603279. Last updated year: 2026. Please use registration number 3034603279 when referencing this establishment in official correspondence.
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