Data / Medical devices / United States / Utah Medical Products, Inc.

Utah Medical Products, Inc.: FDA-registered device maker in Midvale, UT, United States, 43 510(k) clearances

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

Utah Medical Products, Inc. is registered with the FDA (registration 1718873) in Midvale, UT, United States. It lists 37 device types. The FDA files 43 510(k) clearances under its listings, the newest dated August 28, 2015. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 1718873
Address: 7043 South 300 West, Midvale, UT, United States, 84047
Owner or operator: UTAH MEDICAL PRODUCTS, INC. (1718873)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: July 3, 1992
Registered through: 2026
Brand names listed: AROM-COT, BT Cath, CABLE, CATHETERIZATION TRAY, CMI PUMP, CORDGUARD, CVX-RIPE, DELTA-FLOW and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Manufacturer	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Manufacturer	accessdata.fda.gov
Amniotome	HGE	1	Manufacturer	accessdata.fda.gov
Apparatus, Exhaust, Surgical	FYD	2	Manufacturer	accessdata.fda.gov
Arterial Blood Sampling Kit	CBT	1	Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Repackager or relabeler	accessdata.fda.gov
Cannula, Manipulator/Injector, Uterine	LKF	2	Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer	accessdata.fda.gov
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor	PFJ	2	Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Manufacturer	accessdata.fda.gov
Catheter, Continuous Irrigation	GBQ	1	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Manufacturer	accessdata.fda.gov
Catheter, Peritoneal Dialysis, Single Use	FKO	2	Manufacturer	accessdata.fda.gov
Catheter, Suprapubic (And Accessories)	KOB	2	Manufacturer	accessdata.fda.gov
Catheter, Umbilical Artery	FOS	2	Manufacturer	accessdata.fda.gov
Catheter, Urethral	GBM	2	Manufacturer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Manufacturer	accessdata.fda.gov
Condom	HIS	2	Manufacturer	accessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)	HHK	2	Manufacturer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Manufacturer	accessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)	HGI	2	Manufacturer, Specification developer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer, Specification developer	accessdata.fda.gov
Extractor, Vacuum, Fetal	HDB	2	Manufacturer	accessdata.fda.gov
Filter, Infusion Line	FPB	2	Manufacturer	accessdata.fda.gov
Hood, Oxygen, Infant	FOG	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Specialized Obstetric-Gynecologic	KNA	2	Manufacturer	accessdata.fda.gov
Intrauterine Tamponade Balloon	OQY	2	Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Manufacturer, Specification developer	accessdata.fda.gov
Light, Examination, Medical, Battery Powered	KYT	1	Manufacturer	accessdata.fda.gov
Monitor, Pressure, Intrauterine	KXO	2	Manufacturer	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	2	Manufacturer	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Manufacturer	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Manufacturer	accessdata.fda.gov
Transducer, Pressure, Intrauterine	HFN	2	Manufacturer	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Manufacturer	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
August 28, 2015	K143424	UTAH CVX-RIPE	PFJ	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
January 23, 2013	K123310	FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)	GEI	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
January 11, 2011	K101535	BT-CATH	OQY	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
May 23, 2007	K063611	SALINE/ CONTRAST MEDIA INFUSION CATHETER	LKF	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
September 25, 2000	K001874	PERIPHERALLY INSERTED CENTRAL CATHETER	LJS	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
May 23, 2000	K000974	FOWLER ENDOCURETTE, MODEL CUR-XXX	HHK	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
March 17, 1997	K955663	ABC IN-LINE BLOOD SAMPLING KIT	CBT	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
February 10, 1997	K964526	LIBERTY RECTAL PELVIC FLOOR EXERCISER	KPI	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
July 10, 1996	K961424	INTRAN 500	HFN	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
June 27, 1996	K960496	LIBERTY LITE PFS SYSTEM	KPI	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
March 27, 1996	K960255	CERAMIC BLADE ELECTRODE	GEI	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
February 20, 1996	K955443	INTRAN PLUS	HFN	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
December 21, 1995	K954619	CORDGUARD II	KNA	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
August 28, 1995	K952981	FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC	FYD	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
May 5, 1995	K942725	CMI VELVET TOUCH VACUUM EXTRACTOR	HDB	Substantially Equivalent	Columbia Medical & Surgical, Inc.	accessdata.fda.gov
April 11, 1995	K943448	LUMIN	LKF	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
April 6, 1995	K951032	FINESS I (DERMATOLOGIC APPLICATION)	GEI	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
August 2, 1994	K940953	UMBILI-CATH-S	FOS	Substantially Equivalent	Gesco Intl., Inc.	accessdata.fda.gov
July 29, 1994	K940952	UMBILI-CATH-S-DL	FOS	Substantially Equivalent	Gesco Intl., Inc.	accessdata.fda.gov
May 16, 1994	K941672	URI-CATH CATHETER	GBM	Substantially Equivalent	Gesco Intl., Inc.	accessdata.fda.gov
May 11, 1994	K941232	THORA-CATH	JOL	Substantially Equivalent	Gesco Intl., Inc.	accessdata.fda.gov
April 29, 1994	K940871	UMBILI-CATH-P	FOS	Substantially Equivalent	Gesco Intl., Inc.	accessdata.fda.gov
April 7, 1994	K932128	CMI E-Z FLO BULB P.N. 701	FFY	Substantially Equivalent	Columbia Medical & Surgical, Inc.	accessdata.fda.gov
March 16, 1993	K923591	PALA-NATE	BTR	Substantially Equivalent	Gesco Intl., Inc.	accessdata.fda.gov
March 18, 1992	K915763	MODIFIED DISPOSABLE FETAL VACUUM	HDB	Substantially Equivalent	Columbia Medical & Surgical, Inc.	accessdata.fda.gov
September 18, 1991	K905263	UTAH ESSU	HGI	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
May 9, 1991	K910788	CMI TENDER TOUCH VE #303TT AND 404TT	HIS	Substantially Equivalent	Challenge Mfg., Inc.	accessdata.fda.gov
November 27, 1989	K895446	CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.)	HDB	Substantially Equivalent	Challenge Mfg., Inc.	accessdata.fda.gov
June 1, 1989	K893204	MUC-X	BSY	Substantially Equivalent	Island Medical	accessdata.fda.gov
October 25, 1988	K884061	ADD-A-CATH	KOB	Substantially Equivalent	Femcare , Ltd.	accessdata.fda.gov
September 9, 1988	K882647	GESCO CATHETERIZATION TRAY	GBQ	Unknown	Gesco Intl., Inc.	accessdata.fda.gov
June 13, 1988	K881967	CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.)	HDB	Substantially Equivalent	Challenge Mfg., Inc.	accessdata.fda.gov
June 13, 1988	K881306	CMI VACUUM DELIVERY SYSTEM #003C AND #004C	HDB	Substantially Equivalent	Challenge Mfg., Inc.	accessdata.fda.gov
October 13, 1987	K872221	DIALY-NATE SET & DIALY-NATE CATHETER	FKO	Substantially Equivalent	Gesco Intl., Inc.	accessdata.fda.gov
February 26, 1987	K862873	IUC - INTRAUTERINE CATHETER	KXO	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
July 17, 1986	K861783	DISPOSABLE STOPCOCK	DTL	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
June 18, 1986	K861090	NUTRI-CATH - FEEDING TUBE	KNT	Substantially Equivalent	Gesco Intl., Inc.	accessdata.fda.gov
March 25, 1985	K842352	PRESSURE MONITORING KIT	DRS	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
March 25, 1985	K841788	UTAH DISPOSABLE PRESSURE TRANSDUCER	DRS	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
July 9, 1982	K821814	HEMO-NATE L-P KIT	KDD	Substantially Equivalent	Int'L Corp.	accessdata.fda.gov
August 10, 1979	K791177	DISPIRO	BZG	Substantially Equivalent	Utah Medical Products, Inc.	accessdata.fda.gov
February 27, 1979	K781815	HEMO-NATE SYRINGE BLOOD FILTER	FPB	Substantially Equivalent	Gisco Intl.	accessdata.fda.gov
November 22, 1978	K780479	DELTA-FLOW	KRA	Substantially Equivalent	Tri-Delta Intl.	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 16, 2015	72462	Class II	Terminated	Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape,	Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where the seal between the Tyvek lid and the PETG tray on one side of the tray had been compromised.	accessdata.fda.gov
June 4, 2013	65374	Class II	Terminated	Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device, Product Usage: Deltran is a disposable pressure transducer that p	Utah Medical Products, Inc. is recalling certain Deltran Disposable Pressure Transducer Kits due to complaints related to packaging integrity of the sterile packaged devices.	accessdata.fda.gov
June 16, 2008	48679	Not yet classified	Terminated	Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, Utah Medica	Possibility of compromised package sterility prior to the expiration date.	accessdata.fda.gov

Compare with other makers

Updated November 6, 2015. 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.