Who else makes this device?

Name: Capillary Adapter Cleaning Kit
Brand: Capillary Adapter Cleaning Kit

Capillary Adapter Cleaning Kit · Electrode, Ion Specific, Potassium → Clinical Chemistry

2manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

1recall

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code CEM
Manufacturer	City	Province	Registered as	Device types
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56

Record

Regulatory record for Capillary Adapter Cleaning Kit
Listed by	Medica Corp., United States
FDA product code	CEM
Device type	Electrode, Ion Specific, Potassium
Device class	Class 2
Regulation	21 CFR 862.1600
Establishment	Repacker / relabeller, Manufacturer
510(k)	K864872
Record published	2018-12-04

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 4 to 25 °C

Catalogue Numbers

Catalogue numbers for Capillary Adapter Cleaning Kit
Catalogue number	Size	Status
2292		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Nova	Nova Biomedical Corporation	8
Stat Profile	Nova Biomedical Corporation	7
Potassium electrode	Roche Diagnostics Gmbh	4
Potassium Electrode	Diamond Diagnostics Inc.	3
Synermed®	Infrared Laboratory Systems LLC	3
Architect	Abbott Laboratories	3
Phoenix Diagnostics, Inc.	Phoenix Diagnostics, Inc.	2
I.S.E. K	Randox Laboratories Limited	2
Pointe Scientific, Inc.	Horiba Instruments Incorporated	2
Potassium Electrode	Medica Corp.	2
Na/K Solution Pack	Medica Corp.	2
Selectra	VitalScientific B.V.	2

Showing 12 of 93. All products under Electrode, Ion Specific, Potassium

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K220396	2023-09-26
K112788	2011-10-20
K961326	1996-06-21
K844044	1984-11-27

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2025-12-31	Class II	Nonconforming Material/Component	A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.	1,578 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Capillary Adapter Cleaning Kit