Data / Medical devices / United States / Ekla Corporation

Ekla Corporation: FDA-registered device maker in Naperville, IL, United States, 4 510(k) clearances

Name: Ekla Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ekla Corporation is registered with the FDA (registration 3008733163) in Naperville, IL, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 29, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008733163
Address: 1707 Quincy Ave Ste 127, Naperville, IL, United States, 60540
Owner or operator: EKLA Corporation (10035863)
Roles: Repackager or relabeler
First device listed: August 5, 2020
Registered through: 2027
Brand names listed: EKLA 1000cc Pressure Infusion Bag with clear back, EKLA 1000cc Pressure Infusion Bag with mesh back, EKLA 3000cc Pressure Infusion Bag with clear back, EKLA 3000cc Pressure Infusion Bag with mesh back, EKLA 500cc Pressure Infusion Bag with clear back, EKLA 500cc Pressure Infusion Bag with mesh back, EKLA Digital Stick Thermometer; V01-1008, EKLA FINGER PULSE OXIMETER, E02-1001 and more

Devices it lists

Device	Product code	Class	Role	Source
Continuous Measurement Thermometer	FLL	2	Repackager or relabeler	accessdata.fda.gov
Infusor, Pressure, For I.V. Bags	KZD	1	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 29, 2023	K220458	UltraFlo-R Push Button Blood Collection Set	JKA	Substantially Equivalent	Innovative Medical Technologies, Inc.	accessdata.fda.gov
September 19, 2017	K163135	Finger Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Fitfaith Technology Co.,Ltd	accessdata.fda.gov
August 24, 2016	K160802	Infrared Forehead Thermometer, FT-100A	FLL	Substantially Equivalent	Hangzhou Universal Electronic Co., Ltd.	accessdata.fda.gov
December 13, 2010	K102718	DIGITAL THERMOMETER; DIGITAL THERMOMETER	FLL	Substantially Equivalent	International Regulatory Consultants, LLC (Irc)	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 20, 2016	80110	Class II	Terminated	NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat. No. VPT1-CASS Product Usage: pregnancy test	Incorrect hCG results	accessdata.fda.gov

Compare with other makers

Updated September 29, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.