510(k) · Cleared

Cleared

Bayer Immuno 1 Her-2/Neu Assay

K992228510(k) TraditionalCleared Sep 29, 2000455-day reviewClass II21 CFR 866.6010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bayer Corp. · NCW System, Test, Her-2/Neu, Monitoring

Cleared on Sep 29, 2000 after a 455-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided: Sep 29, 2000
Review: 455 days
Class: Class II
Product code: NCW
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK992228 Bayer Immuno 1 Her-2/Neu AssayBayer Corp. · 2000
Descendant · cites it directly · 0 of its ownK024017 Bayer Advia Centaur Her-2/Neu AssayBayer Corp. · 2003 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K024017Bayer Advia Centaur Her-2/Neu AssayBayer Corp. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K992228	Bayer Immuno 1 Her-2/Neu Assay	Bayer Corp.	2000	—
+1	K024017	Bayer Advia Centaur Her-2/Neu Assay	Bayer Corp.	2003	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K992228, 2000–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NCW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K024017	Bayer Advia Centaur Her-2/Neu Assay	Bayer Corp.	2003	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K024017 (Bayer Corp., 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NCW devices

NCW System, Test, Her-2/Neu, Monitoring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NCW

FDA has decided no NCW device since 2007.

Median 510(k) review, days · NCW

Too few NCW 510(k)s in any year since 2007 to give a median.

Recalls per year · NCW

1in 2020

2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NCW

No MAUDE report names NCW since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	1	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

The Bayer Immuno 1™ Her-2/neu Assay is an in vitro, diagnostic device intended for use in the quantitative determination of HER-2/neu in human serum. HER-2/neu values obtained may be used in the follow-up and monitoring of patients with metastatic breast cancer. HER-2/neu values should be used in conjunction with information available from clinical and other diagnostic procedures in the management of breast cancer. The clinical utility of the serum measurement of HER-2/neu as a prognostic indicator for early recurrence and in the management of patients on immunotherapy regimens has not been fully established.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992228 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992228: Bayer Immuno 1 Her-2/Neu Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992228

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026