Data / Medical devices / United States / Medtimo, Inc.

Medtimo, Inc.: FDA-registered device maker in Eden Prairie, MN, United States, 6 510(k) clearances and 3 PMA approvals

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

Medtimo, Inc. is registered with the FDA (registration 3013508647) in Eden Prairie, MN, United States. It lists 5 device types. The FDA files 6 510(k) clearances and 3 PMA approvals under its listings, the newest dated May 16, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013508647
Address: 7625 Golden Triangle Dr Ste G, Eden Prairie, MN, United States, 55344
Owner or operator: Medtimo, Inc. (10038397)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: January 30, 2019
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Electrocardiograph	DRX	2	Complaint file establishment	accessdata.fda.gov
Implant, Intragastric For Morbid Obesity	LTI	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Neuromodulator For Obesity	PIM	3	Complaint file establishment	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Complaint file establishment	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Complaint file establishment, Manufacturer, Specification developer	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
May 16, 2024	K241039	ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)	KNT	Substantially Equivalent	Reshape Lifesciences	accessdata.fda.gov
February 15, 2023	K230131	ReShape Calibration Tubes	KNT	Substantially Equivalent	Reshape Lifesciences	accessdata.fda.gov
July 28, 2022	K221898	Gastrointestinal Boundary Identifier (GIBI HD)	KNT	Substantially Equivalent	Reshape Lifesciences	accessdata.fda.gov
June 7, 2022	K220455	Lap-Band System Calibration Tube	KNT	Substantially Equivalent	Reshape Lifesciences	accessdata.fda.gov
July 11, 2013	K130424	STIMEL-03	IPF	Substantially Equivalent	Stimel, Ltd.	accessdata.fda.gov
July 9, 2001	K002838	GASTRIC SUCTION AND DRAINAGE CATHETER	KNT	Substantially Equivalent	Bioenterics Corp.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 8, 2016	P160001	OBALON BALLOON SYSTEM	LTI	42	July 18, 2022	accessdata.fda.gov
January 14, 2015	P130019	MAESTRO RECHARGEABLE SYSTEM	PIM	19	February 15, 2019	accessdata.fda.gov
June 5, 2001	P000008	LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM	LTI	46	July 11, 2025	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
May 23, 2019	85050	Class II	Completed	Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification pr	During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiat	accessdata.fda.gov
October 14, 2016	75475	Class II	Terminated	ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and	ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.	accessdata.fda.gov
May 4, 2016	74781	Class II	Terminated	ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in ob	Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.	accessdata.fda.gov

Compare with other makers

Updated May 16, 2024. 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.