Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2132111

FEI Number

1000140026

Entity Name

R & D BATTERIES, INC.

City/State/Country

Burnsville, MN, US

Establishment Address

3300 CORPORATE CENTER DR., Burnsville, MN 55306, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

R & D BATTERIES, INC. (Owner Number: 9006991)

Owner / Operator Contact Address

3300 CORPORATE CENTER DR., --, Burnsville, MN 55306, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K951282

PMA Number

N/A

All Registered Proprietary Names

5536-P 6429 5875 5536 5860 5624-I 5601, 5602, 5624, 5626 5017 5952 5224 5603 5877 5063 6053 5003 5962 5077 5097 5027 5027FP 5015, 5192, 5482 5098, 5013, 5097 5110 6068 6212 6470-A 5104 5243 5481 6579 6094 5674 5140 5975 6370 5183 5502 5444 5097 5013 5128 5135 5025 5296, 5479, 5351, 5470 5113 5164, 5272, 5260 5181 6320 5073 5410 6296-I 9296-I 6296 6084 5899 5256, 5235, 5506, 5050 5293 RECHARGEABLE BATTERIES 5052

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2015-08-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2015-08-10
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2012-02-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-02-14
FCO	Box, Battery, Rechargeable	Gastroenterology, Urology	Class 1	876.1500	2012-02-16
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2015-08-10
HPQ	Headlamp, Operating, Ac-Powered	Ophthalmic	Class 2	886.4335	2015-08-10
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2015-08-10
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2015-08-10
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2015-08-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2015-08-10
IYX	Camera, Scintillation (Gamma)	Radiology	Class 1	892.1100	2012-02-16
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2012-02-16
FCO	Box, Battery, Rechargeable	Gastroenterology, Urology	Class 1	876.1500	2015-08-10
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2012-02-16
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2015-08-10
FCO	Box, Battery, Rechargeable	Gastroenterology, Urology	Class 1	876.1500	2015-08-10
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2015-08-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2015-08-10
FCO	Box, Battery, Rechargeable	Gastroenterology, Urology	Class 1	876.1500	2015-08-10
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2012-02-16
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2012-02-16
ILQ	System, Communication, Powered	Physical Medicine	Class 2	890.3710	2001-11-20
FKP	System, Dialysate Delivery, Single Patient	Gastroenterology, Urology	Class 2	876.5820	2012-02-16
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2012-02-16
FAP	Cystometric Gas (Carbon-Dioxide) On Hydraulic Device	Gastroenterology, Urology	Class 2	876.1620	2012-02-16
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2015-08-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2015-08-10
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2012-02-16
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2012-02-16
FCO	Box, Battery, Rechargeable	Gastroenterology, Urology	Class 1	876.1500	2001-11-20
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2015-08-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2015-08-10

Official Correspondent

Christopher Noddings

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

R & D BATTERIES, INC.

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2018	Optovue, Inc.	2	iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0010-2018	Optovue, Inc.	2	iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.

Similar Registrations

Registration Number	Establishment Name	Location
3027485564	HINCKLEY MEDICAL, INC. dba ONEDOSE	Bloomington, MN, US
3008386534	seca Medical Measuring Systems (pinghu) co. ltd.	Pinghu Zhejiang, CN
3012935929	A&D SCALES CO., LTD.	Jincheon-gun Chungbuk, KR
3012696053	HEALTHCHEK NETWORK, LLC	Lake Charles, LA, US
3011065399	Greater Goods, LLC	Saint Louis, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2132111. Last updated year: 2026. Please use registration number 2132111 when referencing this establishment in official correspondence.