DIALITY, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3015349756

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
3015349756
FEI Number
3015349756
Entity Name
DIALITY, INC.
City/State/Country
Irvine, CA, US
Establishment Address
181 Technology Dr Ste 150, Irvine, CA 92618, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Diality Inc (Owner Number: 10091317)
Owner / Operator Contact Address
181 Technology Drive, Suite 150, Irvine, CA 92620, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233798
PMA Number
N/A

All Registered Proprietary Names

Moda-flx Hemodialysis System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2024-08-21
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2024-08-21
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2024-08-21

Official Correspondent

Jahnavi Lokre

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Diality 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
K811830 Cordis Corp. C-DAK DUO-FLUX ARTIFICIAL KIDNEY 1981-09-21
K070320 Edwards Lifesciences Services GmbH EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 2007-06-07
K150880 Outset Medical Tablo Console with Wireless Capability 2015-05-01
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0019-2025 Outset Medical, Inc. 2
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis SYS, with CDX
Z-0029-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System without CDX
Z-0030-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System w/Bibag
Z-0031-2024 Fresenius Medical Care Holdings, Inc. 2
2008T GEN 2 Bibag without CDX

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015349756. Last updated year: 2026. Please use registration number 3015349756 when referencing this establishment in official correspondence.
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