BYFLO LLC

FDA Device Registration & Listing · Mountain House, CA, US · Registration 3042579404

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
3042579404
FEI Number
3042579404
Entity Name
BYFLO LLC
City/State/Country
Mountain House, CA, US
Establishment Address
491 N Napa Ln, Mountain House, CA 95391, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
ByFlo LLC (Owner Number: 10094320)
Owner / Operator Contact Address
30 N Gould St Ste N, Sheridan, WY 82801, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K222125
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-11-23
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-12-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-12-05
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-12-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-12-05

Official Correspondent

Jeyul Thakkar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ByFlo LLC
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
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042579404. Last updated year: 2026. Please use registration number 3042579404 when referencing this establishment in official correspondence.
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