Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015882716

FEI Number

3015882716

Entity Name

GASTROKLENZ INC. DBA CLOUDCATH

City/State/Country

San Francisco, CA, US

Establishment Address

665 3rd Street, Suite 250, San Francisco, CA 94107, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

GastroKlenz Inc. dba CloudCath (Owner Number: 10085457)

Owner / Operator Contact Address

665 3rd Street, Suite 250, San Francisco, CA 94107, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212658

PMA Number

N/A

All Registered Proprietary Names

CloudCath Drain Set - Fresenius Configuration CloudCath Sensor (Sensing Hardware) CloudCath Connect - Patient Monitoring Software CloudCath CloudCath Drain Set - Baxter Configuration

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2022-06-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GastroKlenz Inc. dba CloudCath

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
K822361	Travenol Laboratories, S.A.	DIANEAL SOLUTION EXCHANGE DEVICE #5C4193	1982-08-16
K933687	R & D Batteries, Inc.	R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260	1994-02-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2020	Baxter Healthcare Corporation	2	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

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3015335038	ERIKA DE REYNOSA, S.A. DE C.V.	CD, REYNOSA Tamaulipas, MX
1225714	Fresenius Medical Care Renal Therapies Group, LLC	Waltham, MA, US
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015882716. Last updated year: 2026. Please use registration number 3015882716 when referencing this establishment in official correspondence.