Medical device manufacturer

Bayer Corp.

Bayer Corp. holds 96 FDA 510(k) clearances across 60 product codes. Median elapsed review time is 74 days. openFDA lists 2 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 96
Product codes: 60
Median review: 74 days
Recall records: 2

How does FDA spell Bayer Corp.?

FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published it	Dataset	Matched by
Bayer Corp	device/recall	normalised
Bayer Corp	device/enforcement	normalised
Bayer Corp.	device/510k	normalised
Bayer Corp.	device/recall	normalised

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Bayer Corp. file in?

60 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
CGA	Glucose Oxidase, Glucose	8	84 days	3 March 2003
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	4	49 days	24 November 1999
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	4	83 days	17 December 2002
MMI	Immunoassay Method, Troponin Subunit	4	63 days	29 March 2001
CFR	Hexokinase, Glucose	3	126 days	20 November 2001
GKZ	Counter, Differential Cell	3	59 days	5 February 2001
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	3	162 days	5 July 2001
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	3	160 days	20 August 2001
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	3	205 days	24 July 2002
NBW	System, Test, Blood Glucose, Over The Counter	3	31 days	23 January 2003
CIX	Bromcresol Green Dye-Binding, Albumin	2	55 days	15 September 1999
GKL	Counter, Cell, Automated (Particle Counter)	2	91 days	29 August 1997
JHI	Visual, Pregnancy Hcg, Prescription Use	2	2 days	11 February 2003
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	2	60 days	7 December 1998
JZG	System, Test, Beta-2-Microglobulin Immunological	2	43 days	16 December 1999
KLT	Enzyme Immunoassay, Carbamazepine	2	58 days	18 May 2000
LOJ	Kit, Test,Alpha-Fetoprotein For Testicular Cancer	2	15 days	27 March 2002
NCW	System, Test, Her-2/Neu, Monitoring	2	57 days	30 January 2003
CDD	Radioassay, Vitamin B12	1	56 days	16 December 1999
CDP	Radioimmunoassay, Total Triiodothyronine	1	24 days	12 July 1996
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	1	50 days	27 September 1996
CGI	Radioimmunoassay, Estriol	1	75 days	3 March 1998
CGN	Acid, Folic, Radioimmunoassay	1	128 days	24 January 1996
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	1	109 days	19 December 2000
CHP	Radioimmunoassay, Estradiol	1	36 days	2 May 1995

Showing the 25 they file in most, of 60.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Bayer Corp. had a recall?

openFDA lists 2 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.

Z-1673-2014Class IITerminatedFRN3 April 2014
There is a potential safety risk associated with potentially damaged locking pins within the bracket of non-wireless versions of Continuum systems shipped prior to March 2008.
Z-0066-04TerminatedCHL26 September 2003
Potential for bias shift in pO2 values due to air bubble in sample path

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Bayer Corp. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K024062	ASCENSIA BREEZE BLOOD GLUCOSE METER	CGA	3 March 2003	84
K023944	BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST	JHI	11 February 2003	77
K024017	BAYER ADVIA CENTAUR HER-2/NEU ASSAY	NCW	30 January 2003	57
K024234	ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL	NBW	23 January 2003	31
K022288	COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM	LTJ	17 December 2002	155
K023584	ASCENSIA DEX 2 DIABETES CARE SYSTEM	NBW	20 November 2002	26
K020828	CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM	LTK	24 July 2002	132
K021428	CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM	JFY	5 July 2002	63
K020806	ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY	LOJ	27 March 2002	15
K013568	CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM	DHX	21 December 2001	56

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.