OMADA HEALTH

FDA Device Registration & Listing · S San Fran, CA, US · Registration 3015236197

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
3015236197
FEI Number
3015236197
Entity Name
OMADA HEALTH
City/State/Country
S San Fran, CA, US
Establishment Address
611 Gateway Blvd Ste 120, S San Fran, CA 94080, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Omada Health (Owner Number: 10059585)
Owner / Operator Contact Address
500 Sansome St, Suite 200, San Francisco, CA 94111, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K131395
PMA Number
N/A

All Registered Proprietary Names

Omada Health Blood Pressure Monitor

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 2020-08-17

Official Correspondent

Patrick Curry

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Omada Health
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 3015236197. Last updated year: 2026. Please use registration number 3015236197 when referencing this establishment in official correspondence.
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