Biomerics

Salt Lake City, UT, US

BIOMERICS appears in FDA device records in Salt Lake City, UT. FDA records list 10 510(k) clearances between 1994-12-27 and 2020-02-07, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 10
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Biomerics carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Catheter Research, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 10 510(k) clearances for Biomerics between 1994 and 2020. The busiest year on record is 1998, with 2. The most recent is 2020, with 1.

Clearances by year, as a table

510(k) clearance decisions for Biomerics, by decision year
Year	Clearances
1994	1
1995	1
1998	2
2002	1
2003	1
2012	2
2013	1
2020	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K190259	Vesta RF Cannula	GXI	Substantially Equivalent	2020-02-07
K123258	THE ADVANCE CATHETER FOR HSG AND SIS	LKF	Substantially Equivalent	2013-01-31
K121773	NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE	GXI	Substantially Equivalent	2012-09-21
K120154	INTRAUTERINE INSEMINATION (IUI) CATHETER	MQF	Substantially Equivalent	2012-03-21
K032835	H/S CATHETER SET	LKF	Substantially Equivalent	2003-12-11
K020292	UTERINE INJECTOR	LKF	Substantially Equivalent	2002-04-17
K973839	DISPOSABLE ESOPHAGEAL STETHOSCOPE	BZT	Substantially Equivalent	1998-03-19
K974357	UTERINE MANIPULATOR/INJECTOR	LKF	Substantially Equivalent	1998-02-02
K951345	DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING	BZA	Substantially Equivalent	1995-04-14
K946044	DISPOSABLE GAS SAMPLING LINES	CCK	Substantially Equivalent	1994-12-27

Registered establishments

FDA registered establishments for Biomerics, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3008998256	3008998256	BIOMERICS	6030 W Harold Gatty Drive, Salt Lake City, UT 84116 US	2026	DQR DWF DWS DXC DYB FGB FMI GAD GEI GXI and 7 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1481-2015	HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.	HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.	Class II	2015-04-07	Terminated
Z-1077-06	Zinnanti Injector - 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin''s test. REF TMI1153.	The uterine stop component was not included with the device.		2006-04-24	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain